MalfunctionFMT
GIRAFFE
Received Jul 9, 2026 · Event occurred Jun 11, 2026
Report 3036470679-2026-00107 · MDR key 25764652
Device
Generic name
Warmer, Infant Radiant
Manufacturer
Datex-ohmeda, Inc.Model number
WARMERCatalog number
NA
Lot number
NA
Product problems
- No Flow
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE END USER RESOLVED THE ISSUE. THERE WAS NO GE HEALTHCARE REPAIR. 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 MAINTENANCE RESULTING IN POTENTIAL LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.