MalfunctionFMZ
GIRAFFE OMNIBED CARESTATION
Received May 26, 2026 · Event occurred Apr 28, 2026
Report 3008729547-2026-00044 · MDR key 25279243
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
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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: HCS RESEARCH PARK - 9900 INNOVATION DRIVE, USA WAUWATOSA, WI 53226.
Description of Event or Problem
IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.