inforMED
MalfunctionFMZ

GIRAFFE INCUBATOR CARESTATION

Received Sep 2, 2025 · Event occurred Aug 5, 2025

Report 2112667-2025-06991 · MDR key 22941980

Device

Generic name

Incubator, Neonatal

Manufacturer

Datex-ohmeda, Inc.

Model number

CS1

Product problems

  • Break
  • Break

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DISENGAGEMENT OF TOP SCREW AND THERE IS NO FALL OF HEATER DOOR THUS THIS COMPLAINT IS CONSIDERED TO BE NOT REPORTABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

GE HEALTHCARE 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: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.