Philips Heart Monitor Device Linked to Health Risks in US

A Philips device used by heart patients to monitor their heart rhythm at home has malfunctioned. The U.S. FDA has linked the device to two deaths and 109 cases of health issues, though it did not specify the details of these incidents.

Philips stated that the affected patients are in the United States and that this model is not used in the Netherlands. The device, Mobile Cardiac Outpatient Telemetry (MCOT), is manufactured by Braemar Manufacturing, a Philips subsidiary.

Reports were made from July 2022 to July 2024, indicating the device sometimes failed to transmit heart data to cardiologists, missing critical alerts. The FDA has announced a recall, but Philips clarified this involves a software update, not returning the devices.

Medical professionals must assess whether patients using the device need to be contacted. Philips reported to the NOS that they acted “quickly and proactively,” and the device now functions correctly.

Previously, in 2021, the FDA intervened with Philips’ sleep apnea devices, manufactured by another subsidiary, Respironics, due to foam degradation issues, which led to health complaints and linked deaths. Philips has maintained that no conclusive evidence ties the health complaints to the devices.

Source: NOS

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