FDA Adverse Event
Death
Summary report: N
GE TELEMETRY MONITORING SYSTEM
MDR report key: 24176605
·
Received January 26, 2026
Report
- Report Number
- MW5182712
- Event Type
- Death
- Date Received
- January 26, 2026
- Date of Event
- January 6, 2026
- Report Date
- January 19, 2026
- Manufacturer
- GE HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- 501
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241185 | GE TELEMETRY MONITORING SYSTEM | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | GE HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MAI800 | 0601000026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Death |