GIRAFFE OMNIBED CARESTATION
Received Aug 6, 2025 · Event occurred Jul 11, 2025
Report 3008729547-2025-00069 · MDR key 22728783
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
Description of Event or Problem
IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
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.
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. THEREFORE, THERE WAS NO REPORTABLE MALFUNCTION.