GIRAFFE INCUBATOR
Received Dec 17, 2025 · Event occurred Nov 18, 2025
Report 2112667-2025-09771 · MDR key 23828294
Device
Product problems
- Insufficient Flow or Under Infusion
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE O2 CELL WAS REPLACED TO RESOLVE THE ISSUE. B3 INCIDENT DATE UPDATED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REGULATOR ASSEMBLY SERVO 2 KIT WAS REPLACED TO RESOLVE THE ISSUE.
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. B3 INCIDENT DATE NOT PROVIDED. H4 DATE OF DEVICE MANUFACTURE UNKNOWN AT TIME OF MDR SUBMISSION. 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. THERE WAS NO PATIENT INVOLVEMENT.