The recall was announced by the FDA at the end of August. The agency states that the recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.
Although this recall is not associated with certain BiPAP machines recalled in June 2021 due to the PE-PUR foam issue, it does include some devices that were in the initial recall.
Toxic Plastic Material
Several models of ventilators that are equipped with a “plastic contaminated with a non-compatible material may release volatile organic compounds (VOCs) directly into the machine’s air pathways,” announced the FDA. These toxic VOC’s could cause a range of health issues, from headache and dizziness to immune system reaction to toxic cancer-causing effects.
If the toxic plastic material enters the motor, the machine may abruptly shut down without warning, which means that users might not get enough oxygen pressure, which in turn can increase the risk of respiratory injuries. Or worse: if the machine suddenly stops working, the agency said it “may lead to serious injury or death.”
Philips distributed 386 affected BiPAP machines in the U.S. between Aug. 6, 2020, and Sept. 1, 2021. The company sent a recall letter to customers on Aug. 26 notifying them of the issue.
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- The magnets can potentially affect the functioning of or cause movement of certain implanted metallic medical devices, which could result in injury or death to the mask user or people near the patient wearing the recalled mask, such as a bed partner, who have such devices. Medical devices that could potentially be affected by these magnets include brain stents, aneurysm clips, pacemakers, implantable cardioverter defibrillators, ventriculoperitoneal shunts, ocular implants, magnetic denture attachments, insulin pumps, certain neurostimulators used in and around the neck, cochlear implants or any metallic implanted medical device affected by magnets.
- The magnets could also affect mask users who have metallic objects in their body, such as shrapnel or splinters in their eyes, including people near the patient wearing the affected mask, such as a bed partner.
- Five mask types are affected by this recall: the DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks.
Serious Injuries and Deaths
As of September 6, Philips reported 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to use of the recalled masks. As of August 17th, the FDA had received reports of 44 more deaths associated with Philips Respironics’ first respiratory device recall. This update brings the number of deaths to 168. And 69,000 medical device reports (MDRs) have been related to the recall.