inforMED
MalfunctionFMZ

GIRAFFE OMNIBED

Received Mar 6, 2026 · Event occurred Feb 5, 2026

Report 3036470679-2026-00022 · MDR key 24536129

Device

Generic name

Incubator, Neonatal

Manufacturer

Datex-ohmeda, Inc.

Catalog number

NA

Lot number

NA

Product problems

  • Incomplete or Inadequate Connection

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED COMPLAINT DID NOT INVOLVE A MALFUNCTION THAT WOULD CAUSE THE HEATER DOOR TO FALL OR DISENGAGE. 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 THAT THE HEATER DOOR SHOULDER SCREW DISENGAGED. THERE WAS NO PATIENT INVOLVEMENT.