GIRAFFE OMNIBED CARESTATION
Received Jul 9, 2026 · Event occurred Jun 12, 2026
Report 3036470679-2026-00105 · MDR key 25762625
Device
Generic name
Incubator, Neonatal
Manufacturer
Datex-ohmeda, Inc.Model number
CS1Catalog number
NA
Lot number
NA
Product problems
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
GE HEALTHCARE¿S 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 D4 PRIMARY UDI NUMBER: THIS DEVICE WAS NOT MANUFACTURED FOR SALE IN THE USA AND THEREFORE A USA UDI IS 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 DURING PRE-USE CHECKOUT RESULTING IN OXYGEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.