inforMED
MalfunctionFMT

GIRAFFE WARMER

Received Jan 9, 2026 · Event occurred Dec 10, 2025

Report 2112667-2026-00183 · MDR key 24019462

Device

Generic name

Warmer, Infant Radiant

Manufacturer

Datex-ohmeda, Inc.

Catalog 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 LATCH WAS NOT BROKEN. THERE WAS NO REPORTABLE MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A BROKEN/DAMAGED SIDEWALL LATCH. THERE WAS NO PATIENT INVOLVEMENT.

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. D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.