GIRAFFE
Received Apr 10, 2026 · Event occurred Mar 12, 2026
Report 3036470679-2026-00040 · MDR key 24841747
Device
Generic name
Warmer, Infant Radiant
Manufacturer
Datex-ohmeda, Inc.Model number
WARMERCatalog number
NA
Lot number
NA
Product problems
- No Flow
Patient
1 DA · Female
- Low Oxygen Saturation
Narrative
Description of Event or Problem
THE HOSPITAL ALLEGED A PATIENT DID NOT RECEIVE THE SET OXYGEN PERCENTAGE THROUGH THE BLENDER IN THE GIRAFFE IRS WARMER. STAFF REPORTED THAT THERE WAS NO INDICATION OF THE ACTUAL OXYGEN OUTPUT WHEN A SPECIFIC PERCENTAGE WAS SELECTED. IT WAS ALLEGED THE PATIENT DESATURATED TO APPROXIMATELY 60-65%. AFTER THE PATIENT WAS TRANSFERRED TO ALTERNATIVE RESPIRATORY SUPPORT EQUIPMENT, THE OXYGEN SATURATION LEVEL RECOVERED TO APPROXIMATELY 90-95%. THERE WERE NO REPORTED PATIENT SEQUELAE.
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 A5 AND A6: NO INFORMATION PROVIDED. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.
Remedial action
- Recall