GIRAFFE OMNIBED CARESTATION
Received Aug 14, 2025 · Event occurred Jul 21, 2025
Report 2112667-2025-06528 · MDR key 22804073
Device
Generic name
Incubator, Neonatal
Manufacturer
Datex-ohmeda, Inc.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. 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.