GIRAFFE OMNIBED
Received Nov 14, 2025 · Event occurred Oct 17, 2025
Report 3036470679-2025-00012 · MDR key 23555145
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
THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE O2 SERVO BOARD 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. BLOCK H4: DATE OF DEVICE MANUFACTURE YEAR IS 2005. THE MONTH OF MANUFACTURE WAS UNAVAILABLE AT TIME OF MDR FILING. 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 OXYGEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.