MalfunctionFMZ

GIRAFFE OMNIBED CARESTATION

Received Dec 13, 2025 · Event occurred Nov 17, 2025

Report 3008729547-2025-00104 · MDR key 23797745

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Product code (FMZ)

Manufacturer (Ge Medical Systems Information Technologies - Critikon De Mexico S. De R.l. De C.v.)

Model (CS1)

Device

Generic name

Incubator, Neonatal

Manufacturer

Critikon De Mexico S. De R.l. De C.v.

Model number

CS1

Catalog number

Lot number

Product problems

Detachment of Device or Device Component
Detachment of Device or Device Component

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE HEATER DOOR CAME OFF THE HINGES. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE HINGES WERE RESEATED TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.