BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2132478 · Received June 10, 2011

    Report

    Report Number
    2132478
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    CYBEX INTERNATIONAL, INC.
    Product Code
    ION
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS OPERATING A LEG PRESS UNIT IN AN OUTPATIENT REHABILITATION CLINIC. WHILE IN OPERATION, THE CABLE ON THE LEG PRESS BROKE RESULTING IN THE PATIENT'S LEGS FALLING OFF OF THE PLATE AND JERKING HIM FORWARD. THE PATIENT INDICATED THAT HE WAS OKAY AT THE TIME OF THE INCIDENT AS WELL AS BEFORE LEAVING THE CLINIC. BIOMED WAS CALLED AND THE BROKEN CABLE WAS VERIFIED. REPLACED CABLE AND UNIT WORKED FINE. CONTACTING MANUFACTURER TO SEE WHY A CABLE THAT WAS CRIMPED BY THE VENDOR WOULD BREAK AT THE CONNECTOR END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * EXERCISER, NON-MEASURING ION CYBEX INTERNATIONAL, INC. LEG PRESS *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO OTHER THERAPIES