MalfunctionFMZ
GIRAFFE OMNIBED
Received Jul 7, 2026 · Event occurred Jun 9, 2026
Report 3036470679-2026-00103 · MDR key 25733074
Device
Product problems
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POTENTIAL LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE CUSTOMER DECLINED GE HEALTHCARE SERVICE. NO REPAIR INFORMATION AVAILABLE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. BLOCK 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.