In late March, Philips Medical Systems Inc., Seattle, received a warning letter from the Food and Drug Administration (FDA) noting that the company had failed to rectify problems with some of its automated external defibrillators (AEDs), and those failures had led to deaths.
The letter stated that some of the company’s devices did not conform with the Current Good Manufacturing Practice requirements of the Quality System regulation.
Specifically, the FDA had received 87 complaints since January 2008, including one death, about magnets being detached or missing from the handle of HS1 AED pads cartridges, according to the letter. The FDA states that design changes were approved in 2009, but Philips had no documentation showing that validation or verification evaluating the effectiveness of the corrective action had been performed.
Another violation involved failure to adequately implement changes in methods and procedures needed to correct quality problems in its FR2 AED. The FDA says that a complaint received in August 2009 stated the AED failed to operate during an attempted rescue, leading to a death. That AED had previously failed self tests five times but was cleared by the customer with battery insertion tests.
Philips was to address the situation by labeling the FR2 AED with a note instructing users to contact Philips for service if the customer had self test failures cleared with a battery insertion test. However, the FDA said that as of Aug. 9, 2010, no corrective actions had been conducted.
The FDA also noted Philips had not corrected failures of components due to moisture ingress in high-humidity environments.
The FDA warned that Philips had not set up adequate methods to document complaints and investigations of those complaints or to set up a system to determine which complaints should be forwarded to the FDA.
The letter instructed Philips to take prompt action to correct the violations and warned that failure to do so could result in regulatory action, which could include fines.
The FDA states that an outside expert consultant must conduct an audit to ensure that Philips is complying with the manufacturing and quality assurance system. By Sept. 22, Philips’ CEO must verify that the company has initiated or completed all corrections required in the report.