| Developers: | Philips Healthcare |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
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2024
Breathing equipment works with errors and becomes clogged. First death recorded
In early October 2024, Philips began recalling ventilators due to serious problems in the operation of the equipment. The recall concerns the IVL systems Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal and is characterized by the highest level of danger, as the problem threatens the lives of patients. The recall affects about 90,000 ventilators worldwide, including about 67,000 in the United States, Philips said.
When analyzing defective devices, many software errors were identified, including inaccurate display of the concentration of oxygen supplied to the patient, false alarms about the loss of power or battery discharge, inaccuracies in volume measurement, and much more. In addition, the internal sensors of the device can become clogged, which distorts the results of measurements of pressure, volume or speed of air flow. Nine people were injured and another person died as a result of these problems, according to US regulators.
In mid-July, Philips Responics sent an emergency patch to all affected customers asking them to immediately update the device's software to the latest version, as well as install a Philips-approved particulate filter to prevent contamination of internal equipment parts. This notice did not report new safety concerns threatening the health of patients. However, in the end, Philips Responics was still forced to withdraw the defective equipment from the market.
This is not the first such case, since since the beginning of 2021, Philips has recalled millions of SIPAP devices and other respiratory devices due to safety problems. Among them was a major recall related to the use of dangerous noise-absorbing foam, which is potentially capable of decomposing and entering the respiratory tract. In April 2024, Philips recalled defective products and soon settled claims for harm to health in the amount of $1.1 billion.[1]
Philips recalls defective ventilators that suddenly turn off ventilation
On May 13, 2024, the US Food and Drug Administration (FDA) announced the recall of defective Philips Respironics ventilators. The use of these devices can trigger the death of patients.
The problem was identified in the IVL devices Trilogy Evo, Trilogy EV300, Trilogy Evo O2 and Trilogy Evo Universal. They are designed to care for people who need help breathing: the devices provide ongoing or periodic support. The devices are suitable for use in medical and home conditions, as well as in non-emergency vehicles, for example, in a wheelchair or private car.
Due to a software problem, defective IVL devices can issue a "Battery Discharged" or "Power Loss" alarm, although sufficient power is available. This leads to a sudden shutdown of ventilation. As a result, therapy is discontinued to the patient, which can cause serious adverse health effects, including hypoventilation and death.
The problem affects 90,905 devices that were distributed from March 20, 2019 to February 16, 2024. As of May 13, 2024, there are no reports of deaths or serious injuries associated with the specified defect. To fix the error, you need to update the software of the devices to version 1.05.06.00, in which the problem is solved. The software is available for free download. If an update fails for any reason, medical professionals should not leave patients unattended while the device is running on battery power. In addition, it is recommended to have an alternative ventilation system for connection if necessary.[2]
2023
Recall of 73 thousand defective ventilators, which get dirt and dust
On August 14, 2023, the US Food and Drug Administration (FDA) announced another recall of defective ventilators manufactured by Philips. The use of defective devices can have dire consequences - up to the death of patients.
The problem affects the solutions of Trilogy Evo O2 EV300, Trilogy Evo O2, LifeVent EVO2, Trilogy Evo, Garbin Evo, Aeris Evo and Trilogy Evo Universal Ventilator. The devices provide artificial ventilation of the lungs with constant positive pressure (CPAP). The devices are designed for children weighing 2.5 kg or more and adults. Devices are used in medical institutions, as well as for non-emergency transportation of patients. The Trilogy Evo O2 EV300 and Trilogy Evo models can also be used by people needing mechanical ventilation at home.
It is reported that dust and dirt from the environment may accumulate in the air path of the recalled devices. This can lead to accumulation of deposits capable of blocking the vents. As a result, the device will no longer supply the required air pressure or air volume/flow. In this case, patients may not receive enough oxygen (hypoventilation), and carbon dioxide will accumulate in their blood.The result can be serious harm to health, and in the worst case, death. A recommendation to eliminate the potential problem is the mandatory use of a filter that prevents solid particles from entering the duct of the apparatus.
Philips received 542 reports of this problem. As of mid-August 2023, two cases of harm to health and one deceased are known. The recall program includes about 73 thousand defective ventilators, which were delivered to the market from March 26, 2019 to March 22, 2023. The problem can be solved by using a particulate filter.[3]
Recall of 57 thousand devices due to a faulty air flow sensor
On June 2, 2023, the US Food and Drug Administration (FDA) disseminated information that Philips was forced to initiate another program to recall defective breathing apparatus.
As stated in the published notice, this time the problem affects the Trilogy Evo series artificial lung ventilation (IVL) devices manufactured by Philips Responics. Equipment may fail due to a faulty air flow sensor.
 | Debris particles from the environment can accumulate on the internal sensor, causing partial blockage, which can affect the accuracy of determining the pressure and volume of the air flow. The malfunction caused by this problem can lead to a deterioration in the patient's condition - up to hypoxemia - is noted in the notification. |  |
To prevent failures, the manufacturer recommends installing a particulate filter, the use of which was previously optional. This filter must be changed once a month or when using a ventilator with different patients. It is emphasized that the installation of a particulate filter does not require changing the therapy settings. To receive alarms, you can choose one of several options depending on the treatment being performed - "Low respiratory volume," "Small minute ventilation," "Low inhalation pressure," etc.
In total, the defect affects 57,395 devices. According to the FDA classification, the recall corresponds to category I (Class I), which indicates a high significance of the problem. How many patients may have suffered as a result of the identified malfunction is not reported. Philips Responics continues to identify the causes of marriage.[4]
Recall of defective breathing equipment
On April 3, 2023, the U.S. Food and Drug Administration (FDA) announced a new recall of Philips' breathing equipment. The revealed defect in the artificial lung ventilation (IVL) devices of the Trilogy Evo series leads to the fact that the patient receives insufficient oxygen.
Philips Responics warned about the problem on March 1, 2023. The defect affects instruments such as Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300. The equipment is designed for non-invasive and invasive ventilation of the lungs. The devices are suitable for respiratory support for patients with chronic diseases and in critical condition in various departments of the hospital. At the same time, intelligent algorithms and a multi-level alarm system ensure the adaptability of therapy.
The FDA notice states that the recall of ventilators falls under the Class I category - this is the most serious type. The issue affects just under 63,000 devices shipped worldwide. It turned out that an internal sensor for measuring oxygen concentration can give readings exceeding the actual values. In this case, the volume of oxygen delivered will deviate from the norm.
Philips Responics says that medical facilities can continue to use ventilators, provided the oxygen content in the patient-inhaled mixture is monitored. An external monitor can be used for this. The company also recommended that clinicians have a backup device available to quickly switch to another oxygen delivery method if needed. A software update for the defective hardware will be released to fix the issue, it said.[5]
Equipment recall
On February 16, 2023, it became known that Philips would have to re-recall thousands of breathing devices that had previously been recalled due to user health risks.
We are talking about devices for the therapy of snoring and apnea, as well as some other products. Defective equipment used PE-PUR sound-absorbing foam, which could theoretically decompose and enter the respiratory tract. Initially, about 5.5 million devices fell under the recall program, some of which will be recalled again.
According to the Food and Drug Administration (FDA), new problems have been identified in Trilogy 100, Trilogy 200 and Garbin Plus ventilators manufactured by Philips Responics. In the United States, 13,811 devices delivered from March 1, 2022 to September 6, 2022 are subject to recall.
One problem is that the silicone sound-absorbing foam used in place of PE-PUR foam can be separated from the plastic substrate due to impaired adhesion. The material can potentially shift and block the air path, which will reduce the flow of air in the ventilator, and also lead to the alarm of the device. If anxiety is not recognized or taken into account, the patient may experience breathing problems, such as asphyxia, hypoventilation, or hypoxemia, which can be life-threatening.
In addition, Philips found leftover PE-PUR sound-absorbing foam in some refurbished machines that were returned to customers. Further exposure to PE-PUR foam can cause potential health risks, which can lead to serious injuries, irreversible disorders and require medical intervention.[6]
2022
New deaths due to defective breathing equipment
At the end of November 2022 Food and Drug Administration , the FDA reported that it had received more than 90,000 reports of problems, including 260 mentions of deaths, in connection with a massive recall of respiratory devices. Philips
At the end of July 2022, the regulator received from April 1, 2021, about 69 thousand messages related to the malfunction of Philips breathing equipment. These reports include information about 169 deaths. From August 1 to October 31, 2022, another 21 thousand messages were registered and 91 deaths in them.
By, to data FDA foam particles could enter the respiratory tract of patients, causing cancer, pneumonia, asthma, infections, cough, shortness of breath, dizziness, headache and chest pain. In total, in the period from April 2021, when the problem was discovered, to date, about 90 thousand reports of poor-quality medical equipment, as well as 260 cases of death, have been registered.
New Philips CEO Roy Yakobs publicly apologized for the recall of Philips Responics products in October 2022. The recall affected 5.5 million CPAP and BiPAP ventilators, as well as other breathing devices.
In addition to negotiating consent with the US Department of Justice and the FDA, Philips is also facing lawsuits. Philips announced that the company has produced about 4 million spare devices and repair kits to recall sound-absorbing foam. Philips Responics said at the time that its goal was to complete about 90% of production and shipment to customers in 2022.
However, the Dutch medical technology giant faces additional challenges. For example, it recently reported two new potential problems with some redesigned Philips Responics Trilogy ventilators - about 3% of the devices that came under initial recall. The new silicone sound-absorbing foam can separate from the plastic base. In addition, the company reported trace amounts of particulate matter in the airway of some fixed ventilators in the United States.[7]
When recalling devices, a defect was found with sound-absorbing foam and solid particles in the air path
At the end of November 2022, the US Department of Health reports that artificial lung ventilation devices from Philips, converted as part of a massive recall of respiratory devices, have new problems.
The FDA informed Philips that Philips Responics Trilogy's redesigned ventilators have two new potential problems, the agency said in mid-November 2022.
On November 23, 2022, Philips published a press release stating that Trilogy 100/200 devices with potential additional problems account for approximately 3% of the 5.5 million breathing devices that fell under the initial recall, which is approximately 165 thousand devices.
First, the new silicone sound-absorbing foam can separate from the plastic base. The separated foam can affect the operation of the device. For example, silicone foam can block air entry, reducing inhalation pressure. A ventilator alarm may be triggered, such as a low inhalation pressure alarm. Philips installed silicone foam in converted ventilators instead of polyester-based polyurethane (PE-PUR) foam, which could collapse and get into the airways.
In addition, Philips reported trace amounts of particulate matter in the airway of some refurbished fans in the United States. Particulate samples were sent to a third-party laboratory for evaluation. Preliminary results showed that some samples contain polyurethane and debris from the environment. Other samples had only debris from the environment.
The FDA requires the company to provide additional information to understand what caused the new problems. The U.S. agency said it wants to provide informed guidance to patients, caregivers and health care providers.
Philips said it had received a limited number of complaints from the United States and Japan about the new issues. The company claims that the problems are related only to fixed ventilators. The company has temporarily suspended repairs to Trilogy 100/200 devices while it investigates potential problems.[8]
Notes
- ↑ Philips has another Class I level ventilator recall
- ↑ Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction
- ↑ Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That Can Reduce Air Flow to Patients
- ↑ Philips faces new recall of Evo respirators, tagged Class I by FDA
- ↑ Philips Trilogy Evo ventilators face another Class I recall
- ↑ Philips Faces a Recall of Repaired Respiratory Devices
- ↑ More deaths reported in Philips respiratory devices recall
- ↑ Philips’ respiratory devices recall has even more problems
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