GIRAFFE OMNIBED CARESTATION
Received Aug 13, 2025 · Event occurred Jul 18, 2025
Report 3008729547-2025-00075 · MDR key 22796034
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
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED MALFUNCTION OF THE HEATER DOOR WOULD RESULT IN A HEATER TRANSITION ERROR. LOSS OF HEAT WOULD BE TEMPORARY AND MINOR. Â THEREFORE, THERE WAS NO REPORTABLE MALFUNCTION.
Additional Manufacturer Narrative
THE CUSTOMER DECLINED GE HEALTHCARE SERVICE. NO REPAIR INFORMATION AVAILABLE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.
Description of Event or Problem
IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.