BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE SPORT

    MDR report key: 2052408 · Received March 16, 2011

    Report

    Report Number
    1824206-2011-01647
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE BED WAS ALARMING. THE BED WAS INSPECTED AND THEY FOUND THE LEFT HEAD SIDERAIL DETECTION SWITCH CABLE AND GROUND STRAP WERE CUT IN TWO. HE BELIEVES THESE TWO PARTS GOT CAUGHT ON THE FOOT HI/LOW BEARING BLOCK MOUNTING BOLT AND NUT AND WHEN THE HI/LOW FUNCTION WAS RAISED IT CAUSED THE SWITCH CABLE AND GROUND STRAP TO BE CUT IN TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE SPORT AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1