GIRAFFE OMNIBED CARESTATION
Received Apr 22, 2026 · Event occurred Mar 25, 2026
Report 3008729547-2026-00033 · MDR key 24953126
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: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING SERVICE RESULTING IN A BROKEN HEATER DOOR. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DISENGAGEMENT OF THE TOP SCREW AND NO FALL OF THE HEATER DOOR. THEREFORE, THERE WAS NO REPORTABLE MALFUNCTION.