MalfunctionFMZ
GIRAFFE INCUBATOR CARESTATION
Received Apr 28, 2026 · Event occurred Apr 1, 2026
Report 3036470679-2026-00050 · MDR key 25018108
Device
Generic name
Incubator, Neonatal
Manufacturer
Datex-ohmeda, Inc.Model number
CS1Catalog number
NA
Lot number
NA
Product problems
- Inaccurate Delivery
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 SERVO MODULE WAS REPLACED TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.
Description of Event or Problem
IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO INCREASE THE PERCENTAGE OF OXYGEN DELIVERY. THERE WAS NO PATIENT INVOLVEMENT.