According to an online news report posted on cbsnews.com, CPAP customers are suffering while they wait to receive their recall-repaired CPAP machines. The Philips CPAP recall was initiated two years ago, but millions of sleep apnea patients have been left waiting to receive their CPAPs. Many customers are outraged that they have been left without viable options for two years. In June of 2021, Philips began a recall of over five million of its breathing devices due to toxic fume and substances emanating from the devices’ sound abatement foam.
Philips Respironics issued the recall announcement that contained a warning concerning the sound abatement foam “breaking off and blowing into the mouths of patients” who were using the breathing machines. The recall announcement also stated that inhaling the foam particles could result in “serious injury which can be life-threatening.”
Philips manufactures over 40% of the world’s sleep apnea devices. When the company issued its replacement estimates, it stated that the replacement process would be completed in one year. Regardless, it has been nearly two years, and a substantial number of customers have not received their replacement CPAP machine.
Philips Respironics stated that it has now completed production on 90% of the new breathing machine needed to resolve the original recall.
According to the U.S. Food and Drug Administration (FDA), the agency has received nearly 100,000 complaints about the foam breakdown in Philips’ breathing devices. The customer complaints included cancer, infections, and chest pain. There have been 346 reports of death connected to the recalled devices.
Philips Respironics stated that their internal investigation found “no conclusive data linking these devices and the deaths reported.” A Philips Respironics’ spokesperson stated that their additional testing did not find an association between its breathing machines and cancer. However, the FDA said Philips Respironics’ new analysis was “unpersuasive.”
According to Dr. Vikas Jain, a board-certified sleep doctor at Frisco’s Dream Sleep Medicine clinic, the recall of Philips Respironics’ devices has put physicians in a difficult position due to the lack of communication from the company. Dr. Jain stated that he still receives new patients who are unaware that their devices have been recalled, making it challenging to provide sound advice without a clear timetable for when patients will receive a replacement. This situation has caused significant difficulties for both physicians and patients alike.
Doctors are facing difficulties in advising their patients following the recall of Philips Respironics’ devices. Shortly after the recall, the US Food and Drug Administration (FDA) conducted an inspection of a Philips Respironics manufacturing facility located in Pennsylvania. This inspection may shed some light on the cause of the recall and help healthcare professionals make informed decisions regarding their patients’ treatment options. However, until more information becomes available, physicians and patients must remain vigilant and take necessary precautions to ensure their safety.
According to the FDA inspection report, federal inspectors noted that Philips Respironics was aware of an issue with the foam in its breathing devices as far back as 2015 – six years prior to the recall. However, no additional design change or corrective action was taken by the company, as reported by the FDA inspection. This revelation raises concerns about the company’s response to potential safety issues and underscores the need for increased accountability in the medical device industry. Patients and healthcare providers must remain vigilant in ensuring the safety of medical devices, and companies must take prompt action to address any potential safety concerns.
In late 2021, Philips Respironics initiated the recall of nearly 20,000 refurbished devices due to two separate issues. The first issue was the presence of leftover foam particles in some of the reworked devices, while the second issue was that the silicone that replaced the foam, in some cases, was coming unglued and could potentially obstruct the airflow. Last month, the FDA classified this recall as a class one recall, indicating that it is the most serious type. It is worth noting that Gray’s replacement device was not included on the list of recalled devices. Nonetheless, patients and healthcare providers must remain vigilant and stay informed about the latest updates regarding the recall to ensure their safety.
Philips recalled the following devices made between 2009 and April 26, 2021:
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
- Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021, to May 24, 2021, with specific serial numbers.
If you are currently using a Philips Respironics ventilator device that is subject to recall, the FDA recommends that you do not stop or change its usage until you have consulted with your healthcare provider. You should also discuss the use of an inline bacterial filter with your healthcare provider, as this may help filter out any pieces of PE-PUR foam, as mentioned in the Philips recall notification. However, it is important to note that the information provided by Philips has not yet established that these filters can reduce the risks associated with PE-PUR foam. The FDA is currently evaluating this information. Additionally, it is essential to consider that inline bacterial filters may not reduce contact with certain chemicals that could be released from the foam, and they may also increase the resistance to airflow through the device, potentially leading to inadequate ventilation. If your ventilator has an inline bacterial filter, closely monitor it for any buildup of foam particles or airflow problems.
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If you or a loved one have suffered from adverse health effects, including the loss of a loved one due to a recalled Philips breathing machine, contact Parker Waichman LLP today for a free case evaluation. Our attorneys are dedicated to helping those who have been harmed by exposure to toxic chemicals seek justice and obtain the compensation they deserve. We’ll help you determine who is responsible for the damages you’ve suffered and hold them accountable. Call us toll-free at 1-800-YOUR-LAWYER (1-800-968-7529) to receive your free consultation and learn more about your legal options.
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