BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACTION MACHINE - ME 4000

    MDR report key: 3161615 · Received June 5, 2013

    Report

    Report Number
    MW5030472
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    METTLER ELECTRONICS CORP
    Product Code
    ITH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WAS PLACED INTO A HARNESS FOR CERVICAL TRACTION. THE CABLE WAS PRETESTED FOR SLIPPING BY PT. THE CABLE WAS ATTACHED TO THE HARNESS BY THE PT. AS THE CABLE WAS ATTACHED, THERE WAS NO NOTED ABNORMALITY OR FRAYING OF THE CABLE. THE TRACTION PULL WAS INITIATED. WHEN THE PULL REACHED ABOUT 17 LBS ON THE DIGITAL READOUT, THE CABLE BROKE FROM THE CLIP. THE TRACTION HARNESS WAS DISENGAGED FROM THE MOTOR SUDDENLY. 140291-2013-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247842 TRACTION MACHINE - ME 4000 MTD - ME 4000 ITH METTLER ELECTRONICS CORP ME 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR