Philips DreamStation

2023

Discovering a new marriage - it causes patients to burn and start fires

On November 28, 2023, the U.S. Food and Drug Administration (FDA) reported identifying a new problem in Philips' breathing equipment. Defective devices can overheat, which creates a risk of fire, and patients can get burns.

We are talking about DreamStation 2 devices designed for artificial ventilation of the lungs with constant positive pressure (CPAP). These devices were also supplied as a replacement for the recalled DreamStation 1 devices. The equipment is intended for the treatment of obstructive sleep apnea in home and clinical settings. The FDA notice says more than 270 reports of overheating of DreamStation 2 devices were received between August 1 and November 15, 2023.

DreamStation 2

Based on the available data, the department does not believe that the DreamStation 2 security problem is related to the foam used in the device [as in the case of other defective DreamStation devices], the regulator said in a statement.

According to the results of the preliminary investigation, an increase in temperature in DreamStation 2 CPAP sets may be observed due to an electrical or mechanical malfunction. In certain situations, this leads to overheating, accompanied by smoke and fire. Philips says the problems could be related to the humidifier of the devices. Patients and health care providers risk burns if they touch a heater plate or water tank tray. Users are advised to place DreamStation 2 devices away from flammable items. As of the end of November 2023, Philips does not say whether a recall of defective equipment is planned.^[1]

Court proceedings on charges of supplying defective breathing equipment

In mid-June 2023, it became known that Philips was accused of unintentional murder due to faulty breathing devices, including devices used to treat patients with sleep apnea.

More than 200 people filed a complaint in France, accusing Philips of deceptive business practices as well as endangering the lives of others and using harmful substances. In 2021, Philips Responics first announced the recall of millions of continuous positive airway pressure (CPAP), two-level positive airway pressure (BPAP) and mechanical ventilation devices. Most of these devices belong to the first generation DreamStation family. The reason for the recall was the fact that the foam used to douse the sound of the devices can collapse and emit small particles that irritate the respiratory tract. Gases released by the crumbling foam could also be toxic or carry the risk of developing cancer, Philips Responics warned at the time the recall began in June 2021.

Hundreds sue Philips, accuse company of sleep murder over defective breathing equipment

According to one of the lawyers, Christophe Leguevac, three of the plaintiffs accuse the company of unintentional murder, and the media case was called "Respiratory Gate." Leguevak added that a number of factors indicate that Philips has known about the problem since at least 2008, not considering it necessary to take any measures to fix it.

In connection with the recalled devices, Philips Responics is a defendant in several lawsuits and claims, including a complaint filed in mid-June 2023 in France. With the trial at a preliminary stage, Philips press chief Steve Klink said it was too early to draw any conclusions or comment further. Clink added that Philips is working with five certified independent testing laboratories in the United States and Europe and other third-party experts to conduct comprehensive tests and studies of PE-PUR sound-absorbing foam to better assess and identify potential health risks. Results from the first generation DreamStation, System One and DreamStation Go devices show that visible foam degradation is negligible, and emissions of volatile organic compounds and particulate matter associated with foam degradation are within acceptable safety standards and are unlikely to cause tangible harm to patient health.

Since April 2021 American , the regulator FDA has received more than 105 thousand reports of medical devices, including 385 reports of death, presumably related to the destruction of PE-PUR foam or suspected foam destruction.^[2]

Recall of defective devices

On April 7, 2023 U.S. Food and Drug Administration (FDA) , it was reported that Philips Respironics had initiated a repeated recall of a number of devices for artificial lung ventilation (IVL) and treatment. apnea

The initial recall of the defective devices was due to the fact that they contained sound-absorbing foam, which could potentially decompose and enter the respiratory tract of patients. After fixing this problem, it turned out that some sets were assigned incorrect or repeated serial numbers: this happened during reprogramming.

Philips DreamStation

The FDA notice says that duplication of numbers can lead to incorrect therapy, in particular, with factory settings or according to a regimen that was chosen by doctors for another patient. In addition, the device may not provide assistance at all. Improper therapy can lead to a number of negative effects, such as respiratory failure and heart failure. It is possible to cause serious harm to human health. Moreover, in some cases, the use of defective equipment can provoke a fatal outcome. Philips received 43 complaints about the identified problem. Deaths were not recorded.

The REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRUIT and REP DreamStation Auto CPAP, DOM - RECRUIT devices delivered from December 1, 2021 to October 31, 2022 are subject to recall.

We regret the concern this safety notice has caused in patients and health professionals. After a significant capacity build-up, Philips Respironics is now rolling out replacement devices and repair kits needed to restore troubled sleep therapy machines around the world, the company said in a statement.[3]

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