GIRAFFE
Received Jan 28, 2026 · Event occurred Dec 29, 2025
Report 2112667-2026-00575 · MDR key 24199036
Device
Generic name
Warmer, Infant Radiant
Manufacturer
Datex-ohmeda, Inc.Model number
WARMERCatalog number
NA
Lot number
NA
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE ISSUE WAS IDENTIFIED IN THE PLEXIGLASS , WHILE THE LATCH WAS FUNCTIONING CORRECTLY. 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 THE UNIT HAD A BROKEN SIDE PANEL. THERE WAS NO PATIENT INVOLVEMENT.