inforMED
DeathMHX

GE TELEMETRY MONITORING SYSTEM

Received Jan 26, 2026 · Event occurred Jan 6, 2026

Report MW5182712 · MDR key 24176605

Device

Generic name

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Model number

MAI800

Catalog number

5867474-03

Lot number

0601000026

Patient

65 YR · Female

  • Insufficient Information

Narrative

Description of Event or Problem

GE TELEMETRY SYSTEM UPGRADE TO VERSION 3.06 RESULTED IN INTERMITTENT AUDIBLE AND VISUAL ALARM FAILURES IN CENTRAL TELEMETRY MONITORING CENTER WHICH EVOLVED OVER DAYS. THIS IMPACTED MULTIPLE MONITORING STATIONS AND RESULTED IN INEFFECTIVE TELEMETRY MONITORING OF PATIENTS. FAILURE OF ALARM NOTIFICATIONS IMPACTED ABILITY TO TIMELY RECOGNIZE, RESPOND AND INTERVENE TO CARDIAC RHYTHM CHANGES. ADDITIONAL SERVICE INTERRUPTIONS INCLUDED LOSS OF SCREEN VISIBILITY AND LOSS OF DATA.