BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED CARESTATION

    MDR report key: 21595882 · Received March 13, 2025

    Report

    Report Number
    3008729547-2025-00022
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 13, 2025
    Report Date
    April 30, 2025
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    FMZ
    UDI-DI
    00840682116862
    PMA / PMN Number
    K152814
    Removal / Correction Number
    Z-0047-2025 & Z-0048-202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS DISENGAGEMENT OF THE SCREW THAT SECURES THE HEATER DOOR. THEREFORE, THE WAS NO REPORTABLE MALFUNCTION AND THE ISSUE WAS NO ASSOCIATED WITH FDA RECALL NUMBER IS Z-0047-2025 AND Z-0048-2025.

    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 INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586074 GIRAFFE OMNIBED CARESTATION INCUBATOR, NEONATAL FMZ CRITIKON DE MEXICO S. DE R.L. DE C.V. CS1 NA 00840682116862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown