• By:bshaffer

Philips CPAP Recall Severity Upgraded by FDA

A recent recall of Philips CPAP and ventilator devices has been upgraded to Class I by the U.S. Food and Drug Administration. Class I is the most severe type of recall which indicates that a malfunctioning medical device may cause serious health problems or result in death.

The Philips recall was issued June 30, 2021, for multiple models of CPAP, BiPAP and Ventilators made by Philips Respironics. It was initially issued as an unclassified recall, only as a safety notification but has now been officially designated Class 1. The recall involved millions of sleep apnea and ventilator devices. Though Philips has reported no injuries that have occurred, with the Class 1 announcement, the FDA has said that over 100 injuries and 1,200 complaints have been reported for products included in the CPAP/Ventilator recall.

Philips began pulling some of its sleep apnea and ventilator devices from the U.S. market on June 14, 2021, after revealing that some of the devices may pose a risk of exposure to polyester-based polyurethane (PE-PUR) which may breakdown during use. The PE-PUR may degrade into particles which can be ingested and may out-gas chemicals that may be inhaled. An official safety notification was announced by the FDA on June 30, 2021.

Polyester-based polyurethane foam is used as part of many of Philips sleep apnea CPAP and ventilator devices as a sound dampening or sound-abatement component. It has been found to be at risk of degrading or off-gassing, particularly under high heat, high humidity and under unapproved cleaning methods such as ozone cleaning.

PE-PUR exposure may result in difficulty breathing, lung injury, toxic reactions and may increase the risk of cancer. Exposure may cause immediate or longer-term symptoms such as headache, throat irritation, coughing, nausea and vomiting and more serious effects.

Philips has indicated that the recall may affect three to four million devices worldwide, with half of those in the U.S. and mainly involving the first-generation DreamStation CPAP products used to treat sleep apnea. Both Philips and the FDA have stated that people using the devices for non-life sustaining purposes are advised to contact physicians before discontinuing use. People using the devices for life-supporting ventilation should not discontinue the ventilator device but should seek immediate medical advice.


Related Post

VIEW all
insulin pump
Automated Insulin Pumps and Smart Devices Use on Rise Due to Pandemic
  • By:bshaffer

Even the movie industry has noticed the increasing use of smart medical devices. The movie trailer for the animated Pixar film “Turning Red” features a diabetic kid who appears to be wearing an Automated Insulin Pump. The COVID-19 pandemic changed the lives of most people and has led to a restructuring of lifestyle and priorities. Businesses have had to rethink the way they work, some industries have seen dramatic downshifts in usage, while others have seen growing interest. One of …

Woman Undergoes Ninth Surgery to Reverse Hernia Mesh Damage; Legal Action Continues to Mount
  • By:admin

As lawsuits continue to be filed against hernia mesh manufacturers, one patient is about to undergo her ninth surgery to undo the damage caused by the mesh. Carmen Pacheco of Georgetown, Texas, suffered for years after her hernia repair process. The problems triggered by the mesh implanted into her during the procedure caused financial and emotional stress for her and her family. Pacheco and her medical team opted for the mesh implant because the product was marketed to last longer …

knee pain
Aesculap Knee Replacement Lawsuit Update 2018
  • By:admin

A new lawsuit was just filed against Aesculap, a division of B. Braun, regarding a problem with the company’s prosthetic knee replacement devices. According to the suit, the company was aware of the problem with the effectiveness of the bonding agent used in its ceramic-coated knee replacement devices, but did not correct the problem or warn consumers of the risk. The lawsuit alleges a solution does exist. According to the claim, Aesculap Implant Systems has a German patent on a …

Have you been affected by a drug or device listed?