This month, the US Food and Drug Administration (FDA) updated its safety communication on the Philips’ CPAP/BiPAP/ventilator recall to include reporting of medical device reports (MDRs) received from August 1, 2022 to October 31, 2022. More than 21,000 MDRs were received during this time frame, including 91 reports of deaths.
Previously, >21,000 MDRs were received from April 1, 2021 to April 30, 2022, including 126 reports of deaths, and from May 1, 2022 – July 31, 2022, >48,000, including 43 reports of deaths (number of deaths has been updated to reflect Philips’ retrospective review of MDRs).
In a release, Philips states that the vast majority (93%) of the approximately 90,000 MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury.
The FDA’s in-depth review and analysis of these new Philips MDRs will include examining the possible reasons for the increased number of reports. 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.
Although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Because of these limitations, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources. These reports, along with data from other sources, can contribute important information to a medical device’s benefit-risk assessment. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.
In related news, Philips has informed the FDA that the Philips Respironics Trilogy ventilators reworked as a part of the June 2021 recall have two new potential issues. The FDA has requested additional information from Philips to better understand the cause of the issues and to provide informed recommendations to patients, caregivers, and health care professionals.
Issue 1: The new silicone sound abatement foam, installed in the reworked ventilators to replace the polyester-based polyurethane (PE-PUR) foam, may 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.
Issue 2: Trace amounts of particulate matter 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.