MalfunctionFMZ
GIRAFFE OMNIBED
Received Nov 5, 2025 · Event occurred Oct 8, 2025
Report 3036470679-2025-00010 · MDR key 23476698
Device
Product problems
- Microbial Contamination of Device
- Microbial Contamination of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A GE HEALTHCARE FIELD ENGINEER REPORTED THERE WAS NO MOLD. THERE WAS NO REPORTABLE MALFUNCTION.
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.
Description of Event or Problem
THE HOSPITAL REPORTED AN ALLEGATION OF MOLD ON THE CANOPY SEAL OF THE UNIT BEING USED IN THE NICU.