GIRAFFE OMNIBED
Received May 11, 2026 · Event occurred Apr 13, 2026
Report 3036470679-2026-00057 · MDR key 25135180
Device
Product problems
- No Flow
Patient
NA · Unknown
- 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 SENSOR WAS RECOMMENDED FOR REPLACEMENT TO RESOLVE THE ISSUE. BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. 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.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF AUXILIARY OXYGEN DURING A CASE. THERE WAS NO PATIENT INJURY.