GIRAFFE OMNIBED CARESTATION
Received Mar 3, 2026 · Event occurred Feb 1, 2026
Report 3036470679-2026-00017 · MDR key 24501152
Device
Generic name
Incubator, Neonatal
Manufacturer
Datex-ohmeda, Inc.Model number
CS1Catalog number
NA
Lot number
NA
Product problems
- Difficult to Open or Close
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE MALFUNCTION WOULD ONLY AFFECT THE HEATER DOOR NOT OPENING OR CLOSING WHICH IS NOT REPORTABLE. THE HEATER DOOR ITSELF WAS NOT BROKEN. THIS IS NOT A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT THE HEATER DOOR WOULD NOT CLOSE. THERE WAS NO PATIENT INVOLVEMENT.
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. LEGAL MANUFACTURER: GEHC TROUT 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.