Philips Issues Correction for Monitoring Service Application Device

Philips has issued a correction for their “Monitoring Service Application for Mobile Cardiac Outpatient Telemetry MCOT (BTPS-1000)” device.

The company recommends that customers acknowledge receipt of the Urgent Medical Device Correction and review their Frequently Asked Questions for the issue.

The Monitoring Service Application is being corrected “after identifying that some ECG events received into the Monitoring Service Application from July 2022 to July 2024 were not properly routed. As a result, these events were not reviewed by a cardiology technician for potential reporting to the ordering clinician. This may have led to missing information in reports or missed notifications, both of which could have impacted a health care provider’s 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 use of affected product was tied to “109 reported injuries and 2 reports of death.”

The Monitoring Service Application 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.”