BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE DUO BED

    MDR report key: 3002701 · Received February 13, 2013

    Report

    Report Number
    1824206-2013-00983
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPLACED THE CARDIO PULMONARY RESUSCITATION VALVE AND THE ISSUE REMAINS. THE ACCOUNT FOUND THE ISSUE TO BE THE LEFT INTERMEDIATE SIDE RAIL CABLE. THE ACCOUNT FOUND THAT SOME WIRES WERE CUT. THE ACCOUNT WELDED THE WIRES BACK TOGETHER TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT WHEN THEY PRESS THE HEAD DOWN BUTTON AND THEN RELEASE THE BUTTON WHEN THE HEAD SECTION IS AT 45 DEGREES, THE HEAD SECTION CONTINUES TO LOWER. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63936 TOTALCARE DUO BED A/C POWERED ADJSUTABLE HOSPITAL BED FNL HILL-ROM, INC. 150298

    Patients

    Seq Age Sex Outcome Treatment
    1