MalfunctionFMZ
GIRAFFE OMNIBED CARESTATION
Received Feb 10, 2026 · Event occurred Jan 13, 2026
Report 3036470679-2026-00004 · MDR key 24305290
Device
Generic name
Incubator, Neonatal
Manufacturer
Datex-ohmeda, Inc.Model number
CS1Catalog number
NA
Lot number
NA
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.