GIRAFFE STAND-ALONE INFANT RESUSCITATION SYSTEM
Received Mar 11, 2026 · Event occurred Feb 9, 2026
Report 3036470679-2026-00026 · MDR key 24567319
Device
Generic name
Warmer, Infant Radiant
Manufacturer
Datex-ohmeda, Inc.Model number
T-PIECECatalog number
NA
Lot number
NA
Product problems
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED ISSUE WOULD NOT RESULT IN OXYGEN THERAPY BECOMING UNAVAILABLE. THEREFORE, THERE WAS NO REPORTABLE MALFUNCTION.
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 OXYGEN THERAPY UNAVAILABILITY. THERE WAS NO PATIENT INVOLVEMENT.