inforMED
MalfunctionFMZ

GIRAFFE INCUBATOR

Received Oct 28, 2025 · Event occurred Oct 1, 2025

Report 2112667-2025-08536 · MDR key 23405034

Device

Generic name

Incubator, Neonatal

Manufacturer

Datex-ohmeda, Inc.

Catalog number

NA

Lot number

NA

Product problems

  • No Flow
  • No Flow

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

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. BLOCK H4: DATE OF DEVICE MANUFACTURE YEAR IS 2003. THE MONTH OF MANUFACTURE WAS UNAVAILABLE AT TIME OF MDR FILING. 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 RESULTING IN OXYGEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THE CUSTOMER DECLINED GE HEALTHCARE SERVICE. NO REPAIR INFORMATION AVAILABLE.