BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED CARESTATION

    MDR report key: 20987609 · Received December 20, 2024

    Report

    Report Number
    3008729547-2024-00033
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 22, 2024
    Report Date
    March 11, 2025
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    FMZ
    PMA / PMN Number
    K152814
    Removal / Correction Number
    Z-0047-2025 & Z-0048-202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE THERE IS NO DISENGAGEMENT OF THE TOP SCREW AND THERE IS NO FALL OF THE HEATER DOOR. THERE WAS NO REPORTABLE MALFUNCTION AND NO ASSOCIATION WITH FIELD MODIFICATION RELATED TO FDA RECALL NUMBER IS Z-0047-2025 & Z-0048-2025.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS HEATER DOOR ISSUE PER 21 CFR 806 ON 22-OCT-2024. THE FDA RECALL NUMBER IS Z-0047-2025 & Z-0048-2025. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND INSTRUCTIONS FOR INSPECTING, INSTALLING, AND TIGHTENING THE SCREW THAT SECURES THE HEATER DOOR. GEHC WILL REPLACE ALL AFFECTED UNITS. BLOCK A: NO PATIENT INFORMATION PROVIDED AFTER CALLS TO END USER 12/19/24 AND 12/20/24. D4 PRIMARY UDI NUMBER: THIS DEVICE WAS NOT MANUFACTURED FOR SALE IN THE USA AND THEREFORE A USA UDI IS NOT AVAILABLE. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Description of Event or Problem · 0

    THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE BEING ADDRESSED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (Z-0047-2025 & Z-0048-2025). THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061293 GIRAFFE OMNIBED CARESTATION INCUBATOR, NEONATAL FMZ CRITIKON DE MEXICO S. DE R.L. DE C.V. CS1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown