Philips Has Filed 21,000 MDRs in Ventilator Recall

FDA is reporting that Philips has filed 21,000 medical device reports in connection with some of its ventilation and sleep apnea devices in the August through October 2022 period.

FDA posted that its in-depth review and analysis of these new medical device reports will include examining the possible reasons for the increased number of reports.

FDA added the MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.

However, FDA points out on its website that "the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event."

Just a few short days ago Philips said that reworked respirators from the 2021 recall have two new potential issues.

Philips said the first issue deals with the new silicone sound abatement foam, installed in the reworked ventilators to replace the polyester-based polyurethane (PE-PUR) foam.  It could potentially separate from the plastic backing and could impact the performance of the device by potentially blocking the air inlet and thus lowering the inspiratory pressure. If the air pressure is significantly impacted, the device could issue a ventilator alarm, such as the Low Inspiratory Pressure alarm.

The second issue deals with trace amounts of particulate matter that have been found in the air pathway of some reworked ventilators. Particulate samples were sent to a third-party lab for evaluation. Preliminary results show PE-PUR and environmental debris in some samples, and in others only environmental debris.