BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED CARESTATION

    MDR report key: 22060026 · Received May 21, 2025

    Report

    Report Number
    2112667-2025-04235
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    November 15, 2024
    Report Date
    May 21, 2025
    Manufacturer
    DATEX-OHMEDA, INC.
    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
    CO, 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.

    Description of Event or Problem · 0

    AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (RECALL NO. Z-0047-2025 & Z-0048-2025), THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE DESCRIBED IN THE RECALL NO. Z-0047-2025 & Z-0048-2025. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81622 GIRAFFE OMNIBED CARESTATION INCUBATOR, NEONATAL FMZ DATEX-OHMEDA, INC. CS1 NA 00840682116862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown