BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED CARESTATION

    MDR report key: 14619093 · Received June 7, 2022

    Report

    Report Number
    14619093
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 23, 2022
    Report Date
    May 31, 2022
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE SAID SHE WAS ALWAYS AT THE LEFT SIDE OF THE ISOLETTE, (SO FACING IT) SHE WENT TO THE LEFT. SHE CHANGED THE INFANT AND HAD THE LEFT SIDE DOWN. AT THAT TIME, SHE NEEDED TO RETRIEVE MORE BLANKETS AND BENT DOWN AND MOVED THE SIDE UPWARD TO REACH INTO THE DRAWER. SHE PULLED THE DRAWER TOWARD HER TO RETRIEVE A BLANKET AND THAT IS WHEN SHE HEARD THE LOUD NOISE. THE RIGHT SIDE DISENGAGED AND WENT DOWN, PATIENT FOLLOWED AND FELL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665745 GIRAFFE OMNIBED CARESTATION WARMER, INFANT RADIANT FMT GENERAL ELECTRIC CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female Other