Two deaths, 109 injuries in U.S. linked to faulty Philips heart monitor device

At least two deaths and over a hundred injuries have been linked to a malfunctioning heart monitoring device from Philips and its subsidiary, Braemer. The company affirmed in a statement that that the problem was related to mishandled data that either failed to identify serious heart-related abnormalities, or identified them but failed to notify a patient’s healthcare provider as required.

Health services that own the devices were notified of the issue in December. When fully operational, the Mobile Cardiac Telemetry Monitoring is supposed to “process, analyze, display, and report symptomatic and asymptomatic cardiac events” from the electrocardiogram data it receives, according to the U.S. Food and Drug Administration (FDA). That data is then supposed to be reviewed by an appropriate medical professional.

But the device with the model number BTPS-1000 sometimes failed to notify healthcare providers of serious cardiac events during the period from July 2022 to July 2024. “These events include algorithm-identified episodes of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia, and second or third degree AV block,” the FDA wrote in a statement this month.

“The FDA is aware of 109 reported injuries and two reports of death related to this issue.” The FDA said that the there are about 130,000 of the devices on the market, and just over 41,000 were in use. The devices are not used in Europe, a Philips spokesperson told ANP.

The spokesperson confirmed the matter on Friday, but more cautiously said that the deaths “may be linked” to the device. The company argued that the problematic devices did not actually cause harm to the patients, despite the failure to diagnose heart conditions or cardiac events in certain circumstances.

A product recall was voluntarily issued to remotely reconfigure the software on the device, but the equipment did not have to be returned to Philips or California-based Braemer. “The service is now working normally, and with patient safety as our number one priority we continue to methodically work through quality at all levels in a multi-year program,” Philips wrote in a statement this month.

Philips is under extra scrutiny for faulty devices after a years-long affair with the company’s sleep apnea devices. In 2021, the healthcare technology company had to recall millions of home sleep apnea devices after discovering that the insulating foam could crumble and come loose if cleaned with certain agents.

Philips settled this last year for 1.1 billion dollars in claims related to the scandal. Philips previously reached an agreement to compensate American patients for economic damage caused by problems with the devices.