MalfunctionFMZ
GIRAFFE INCUBATOR
Received Aug 20, 2025 · Event occurred Jul 25, 2025
Report 2112667-2025-06637 · MDR key 22852352
Device
Product problems
- No Flow
- No Flow
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 SOLENOID SUPPLY VALVE ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE. 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. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN. THERE WAS NO PATIENT INVOLVEMENT.