MalfunctionFMZ
GIRAFFE OMNIBED CARESTATION
Received Jan 6, 2026 · Event occurred Dec 8, 2025
Report 3008729547-2026-00003 · MDR key 23974704
Device
Generic name
Incubator, Neonatal
Manufacturer
Critikon De Mexico S. De R.l. De C.v.Model number
CS1Catalog number
NA
Lot number
NA
Product problems
- Detachment of Device or Device Component
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 HEATER DOOR WAS 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 THE HEATER DOOR DETACHED AS A NURSE LOWERED THE DOOR WHILE UNIT WAS IN PATIENT USE. THERE WAS NO PATIENT INJURY.