GIRAFFE OMNIBED
Received Dec 31, 2025 · Event occurred Dec 3, 2025
Report 3036470679-2025-00019 · MDR key 23933279
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 O2 CELLS WILL BE REPLACED TO RESOLVE THE ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF AUXILIARY OXYGEN. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
GE HEALTHCARE'S 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. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.