Philips Issues Correction for Monitoring Service Application

Philips and its subsidiary Braemar Manufacturing have issued a correction for the Monitoring Service Application, a service related to Mobile Cardiac Telemetry Monitoring (BTPS-1000).

The Philips (Braemer) Monitoring Service Application software is intended to process, analyze, display, and report symptomatic and asymptomatic cardiac events in ECG data received from compatible devices. The data is then reviewed by qualified health care professionals. It is not intended for use on patients with potentially life-threatening arrhythmias who require inpatient monitoring.

This correction follows identification that some ECG events received into the Monitoring Service Application from July 2022 to July 2024 weren’t properly routed. Due to this, the events weren’t reviewed by a cardiology technician for potential reporting to the ordering clinician.

This might have led to missing information in reports or missed notifications, which could have impacted clinical decision making.

Some of the ECG events received into the application during this time period met criteria to be escalated back to ordering practitioners, but were not escalated to them. These events include algorithm-identified episodes of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia, and second or third degree AV block.

The FDA received reports of 109 reported injuries and two reports of death associated with this issue.

Those potentially affected by the correction were advised to check the Philips Prescriber Response Site at https://prs.gobio.com to review which patients who had outpatient electrocardiogram monitoring may need to have data reprocessed (data collected from July 2022 to July 2024).