GIRAFFE OMNIBED
Received Dec 31, 2025 · Event occurred Dec 3, 2025
Report 3036470679-2025-00020 · MDR key 23933309
Device
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL REVIEW DETERMINED THAT THERE IS NO EVIDENCE OF MOLD OR BACTERIAL GROWTH ON THE CANOPY SEALS. THE MATERIAL WAS NOTED DURING CLEANING AND WAS THE ACCUMULATION OF LINT AND CLEANING SOLUTION RESIDUE. THERE WAS NO REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS CONTAMINATION OF CANOPY SEALS. 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. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.