ADU
Received Apr 25, 2025 · Event occurred Mar 28, 2025
Report 9610105-2025-00004 · MDR key 21907403
Device
Product problems
- Inaccurate Delivery
- Inaccurate Delivery
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT ANESTHETIC AGENT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. DUE TO THE AGE OF THE DEVICE, NO PART WAS AVAILABLE FOR REPAIR. 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: Â DATEÂ OFÂ DEVICEÂ MANUFACTURE YEAR WAS UNAVAILABLE AT TIMEÂ OFÂ MDR FILING. LEGAL MANUFACTURER: HCS HELSINKI - KUORTANEENKATU 2 FINLAND HELSINKI ETELA-SUOMEN LAANI, FIN-00510.