GIRAFFE OMNIBED CARESTATION
Received Aug 12, 2025 · Event occurred Jul 16, 2025
Report 3008729547-2025-00072 · MDR key 22781816
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
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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.
Description of Event or Problem
IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
GE HEALTHCARE 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.