Summary: Philips’ cardiac telemetry Monitoring Service Application did not route some ECG events from July 2022 to July 2024 for cardiology review, potentially causing missed notifications about serious arrhythmias. This error can lead to delayed or omitted clinical action. Affected providers should reprocess data and inform any patients impacted.

Key Takeaways:

  • Philips’ software glitch could result in unreviewed ECG events, which may delay diagnosis and increase the risk of severe patient outcomes.
  • Affected healthcare providers must identify impacted patients using the Philips Prescriber Response Site and ensure they receive appropriate follow-up and care.

Philips has alerted customers of an issue that caused cardiac telemetry monitoring applications to not notify healthcare providers of potentially serious issues.

Philips and its subsidiary Braemar Manufacturing are correcting the Monitoring Service Application, a service related to Mobile Cardiac Telemetry Monitoring (BTPS-1000) after identifying that some electrocardiogram (ECG) events received into the Monitoring Service Application from July 2022 to July 2024 were not properly routed.

Nature of the Issue

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.

Philips is asking all affected customers to check the Philips Prescriber Response Site at https://prs.gobio.com to review which patients who had outpatient ECG monitoring may need to have data reprocessed (data collected from July 2022 to July 2024).

Philips will not communicate with patients directly about this issue. If patients have been impacted as part of this issue, healthcare providers have the responsibility to inform patients and/or update a patient’s care pathway.

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Intended Use of the Software

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.

The use of the affected Monitoring Service Application may cause serious adverse health consequences, including longer periods of undetected or untreated irregular heartbeats (arrhythmias) and death. The FDA is aware of 109 reported injuries and 2 reports of death related to this issue.