ADU
Received Jan 9, 2026 · Event occurred Dec 12, 2025
Report 9610105-2026-00001 · MDR key 24019843
Device
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED MALFUNCTION WOULD NOT AFFECT VENTILATION. THERE WAS NO REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. BLOCK H4: DATE OF DEVICE MANUFACTURE WAS UNAVAILABLE AT TIME OF MDR FILING. LEGAL MANUFACTURER: HCS HELSINKI - KUORTANEENKATU 2 FINLAND HELSINKI ETELA-SUOMEN LAANI, FIN-00510.