GIRAFFE OMNIBED CARESTATION
Received Jan 21, 2026
Report 3008729547-2026-00008 · MDR key 24130438
Device
Generic name
Incubator, Neonatal
Manufacturer
Critikon De Mexico S. De R.l. De C.v.Model number
CS1Catalog number
NA
Lot number
NA
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE HEATER DOOR WAS REPLACED BY THE END USER TO RESOLVE THE ISSUE.
Additional Manufacturer Narrative
GE HEALTHCARE 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. BLOCK B3 INCIDENT DATE NOT AVAILABLE. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A BROKEN HEATER DOOR. THERE WAS NO PATIENT INVOLVEMENT.