GIRAFFE OMNIBED CARESTATION
Received Aug 29, 2025 · Event occurred Aug 2, 2025
Report 3008729547-2025-00084 · MDR key 22922192
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
- No Flow
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE ISSUE WAS NOT RELATED TO AND WOULD NOT CAUSE OXYGEN DELIVERY FAILURE. THERE WAS NO REPORTABLE MALFUNCTION.
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.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OXYGEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.