GIRAFFE OMNIBED
Received Feb 10, 2026 · Event occurred Jan 13, 2026
Report 3036470679-2026-00005 · MDR key 24305291
Device
Product problems
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
GE HEALTHCARE HAS 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. 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 DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE OXYGEN SENSOR FAILURE OCCURRED PRIOR TO PATIENT USE AND MAINTENANCE BY THE END USER WAS NOT PERFORMED. THIS IS A USE ERROR. THERE WAS NO REPORTABLE MALFUNCTION.