inforMED
MalfunctionFMT

PANDA IRES WARMER

Received Mar 5, 2026 · Event occurred Feb 4, 2026

Report 3036470679-2026-00021 · MDR key 24518634

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 UNIT 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. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE SIDE DOOR HINGE WAS BROKEN WHILE THE BED WAS IN USE. THERE WAS NO PATIENT INJURY.