Philips Responics E30 (ventilator)

2022: Recall of defective devices

On August 16, 2022 Ministry of Health USA , another 44 deaths were reported related to the mass recall Philips of Respironics respiratory devices. According to the updated information, the total number of deaths reached 168, and a total of 69 thousand medical equipment reports were submitted in connection with the recall.

The following equipment fell under the review:

• A-Series BiPAP A30
• A-Series BiPAP A40
• A-Series BiPAP Hybrid A30
• A-Series BiPAP V30 Auto
• C-Series ASV
• C-Series S/T and AVAPS
• DreamStation
• DreamStation ASV
• DreamStation Go
• DreamStation ST, AVAPS
• Dorma 400
• Dorma 500
• E30
• Garbin Plus, Aeris, LifeVent
• OmniLab Advanced+
• REMstar SE Auto
• SystemOne ASV4
• SystemOne (Q-Series)
• Trilogy 100
• Trilogy 200

Philips Respironics E30

In 2021, Philips Responics recalled millions of some ventilators, two-level positive airway pressure (BiPAP) devices and continuous positive airway pressure (CPAP) devices. The recall relates to a potential health risk caused by the destruction of polyester polyurethane (PE-PUR) based sound absorption foam. Foam particles can enter the air path of the apparatus, causing a number of potential health problems and toxic, carcinogenic effects for the user.

An in-depth review and analysis of these new MDRs will include exploring possible reasons for the increase in reporting during this time. The MDRs received included both mandatory communications from Philips and voluntary communications from health professionals, consumers and patients. These defective ventilators reported a wide range of injuries for patients, including cancer, pneumonia, asthma, other respiratory problems, infections, headache, cough, shortness of breath, dizziness, nodules and chest pain, said Scott Gottlieb, head of the US Food and Drug Administration.

Philips has also suspended orders for sleep therapy systems for the duration of the Class I recall. The company has been out of the respiratory device market for more than a year. Between 2011 and April 2021, Philips introduced only 30 MDRs related to PE-PUR foam destruction, with eight coming from the US. In this period leading up to the recall, there were no reports of trauma or death to patients. But in May 2022, the US Department of Health confirmed that between April 2021 and April 30, 2022, it received more than 21 thousand reports of medical devices (MDR), including 124 reports of death. For August 2022, the Food and Drug Administration (FDA) includes data for the period that followed the first term, which is more than 48 thousand. MDR and 44 reports of death between 1 May and 31 July 2022.^[1]

2020

Roszdravnadzor allowed Philips to import another 1.3 thousand ventilators

As it became known on August 20, 2020, Roszdravnadzor allowed Philips to import another 1.3 thousand artificial lung ventilation devices (IVL) into Russia. The company received a temporary registration certificate until January 1, 2021 and explained it by uncertainty with a further scenario for the development of the pandemic and the willingness to provide supplies to medical institutions in the event of an emergency.

As Vademec writes with reference to Roszdravnadzor documents, Philips is ready to import up to 1000 Respironics E30 devices developed in the context of the COVID-19 coronavirus pandemic based on CPAP devices of continuous positive pressure in the respiratory tract, which were previously used for home treatment of patients with sleep apnea. The modernized devices received IVL functions, they can be used for both invasive and non-invasive ventilation.

Roszdravnadzor allowed Philips to introduce another 1.3 thousand ventilators

In addition, the manufacturer imports 230 devices of Trilogy Evo devices, as well as 70 Trilogy EV300 devices designed for invasive and non-invasive ventilation with additional monitoring functions for capnometry and pulse oximetry.

The fight against the spread of COVID-19 is not over yet, and you need to be as prepared as possible for emergencies. For our part, as a manufacturer, we are doing everything possible to provide the health care system with modern equipment and ensure the supply of ventilators to Russian clinics, regardless of the scenario of the epidemic, "said Olga Eremeeva, head of the Solutions for Respiratory Therapy at Philips in Russia and the CIS.

In 2020, the Russian government will allocate 7.5 billion rubles to the Ministry of Industry and Trade from the reserve fund for the purchase of ventilators and extracorporeal membrane oxygenation.^[2]

Philips Responics E30 ventilator announcement

In mid-April 2020, Royal Philips introduced the new Philips Responics E30 ventilator, a universal device designed for non-invasive and invasive ventilation of patients with coronavirus infection, and promised to produce 15,000 units a week to combat the pandemic.

Philips Responics E30 can be safely used when a fully functional intensive care ventilator is not available, "explained Frans van Houten, CEO of Royal Philips. - Philips Responics E30 can offer a wide range of treatment options, and we will quickly increase its production to 15,000 units per week as early as April 2020.

Royal Philips introduced the new Philips Responics E30 ventilator, a universal device designed for non-invasive and invasive ventilation of patients with coronavirus infection, and promised to produce 15 thousand units a week to combat the pandemic

Designed for large-scale production, the Philips Responics E30 is optimized to treat patients with respiratory failure and can be quickly set up to perform simple operations. The easy-to-use device offers a wide range of patient therapy and monitoring options and can be used non-invasively and invasively, that is, adapts to the needs of patients with COVID-19.

Philips recently entered into an agreement with the US government in the amount of $647 million, promising to double the supply of ventilators by May and quadruple it by the third quarter of 2020. The company is also partnering with KLM Royal Dutch, the Netherlands' main air carrier, which will create a temporary special cargo air transport to transport medical equipment and other materials from China to the Netherlands.

Other partners helping Philips on the IVL assembly lines are manufacturers Flex and Jabil, which will take over part of the production of old Philips Trilogy devices and new Responics V60.^[3]

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