MalfunctionFMZ
GIRAFFE OMNIBED
Received Nov 7, 2025 · Event occurred Oct 11, 2025
Report 3036470679-2025-00011 · MDR key 23497057
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 HEATER DOOR WAS ORDERED FOR REPLACEMENT TO RESOLVE THE ISSUE. 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 THE LEFT SIDE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.