GIRAFFE OMNIBED CARESTATION
Received Feb 2, 2026 · Event occurred Jan 4, 2026
Report 2112667-2026-00670 · MDR key 24233327
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 BUT DID NOT CONFIRM THE REPORTED ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN DURING A CASE. THE PATIENT WAS SWITCHED TO ANOTHER UNIT AND CASE RESUMED. THERE WAS NO PATIENT INJURY.
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: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE, USA WAUWATOSA, WI 53226.