BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILL-ROM

    MDR report key: 1881885 · Received October 20, 2010

    Report

    Report Number
    MW5017847
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 13, 2010
    Manufacturer
    HILL-ROM
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POST DELIVERY, PT TRYING TO REPOSITION SELF IN BED (MOVE TOWARDS HEAD). THE LIFT-OFF FOOT SECTION DROPPED STRAIGHT DOWN ALLOWING PT'S LEGS AND HIPS TO DESCEND TOWARDS FLOOR. THE PT'S TRUNK AREA REMAINED INTACT ON BED AND NO FALL/INJURIES WERE SUSTAINED. THE LIFT-OFF FOOT SECTION WAS RE-ATTACHED AND SECURED IN BRACKETS AND AUDIBLE CLICK NOTED. SECOND CONCERN: PT(S) ARE EXPERIENCING DIFFICULTY WITH SECURING/MAINTAINING LEGS IN STIR-UP(S) DURING BIRTHING PROCEDURE. RECOMMENDATION: HAVE REQUESTED THE HILL-ROM REP TO RETURN FOR ADDITIONAL IN-SERVICES ON THE BIRTHING BEDS (TO INCLUDE ALL STAFF USING BEDS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HILL-ROM AFFINITY 4 BIRTHING BEDS HDD HILL-ROM BIRTHING BED

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other