MalfunctionBSZ
ADU
Received Mar 11, 2025 · Event occurred Feb 11, 2025
Report 9610105-2025-00002 · MDR key 21572183
Device
Product problems
- Failure to Run on Battery
- Failure to Run on Battery
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE BATTERY WAS REPLACED TO RESOLVE THE ISSUE. BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. Â LEGAL MANUFACTURER: HCS HELSINKI - KUORTANEENKATU 2 FINLAND HELSINKI ETELA-SUOMEN LAANI, FIN-00510.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A LOSS OF MECHANICAL VENTILATION DUE TO BATTERY FAILURE. THERE WAS NO PATIENT INJURY.