MalfunctionFMZ
GIRAFFE OMNIBED CARESTATION
Received Mar 12, 2026 · Event occurred Feb 11, 2026
Report 3036470679-2026-00028 · MDR key 24580611
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
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE O2 SENSORS WERE REPLACED TO RESOLVE THE ISSUE. BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. 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 DURING A CASE. THERE WAS NO PATIENT INJURY.