BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIODEX

    MDR report key: 215021 · Received March 16, 1999

    Report

    Report Number
    215021
    Event Type
    Malfunction
    Date Received
    March 16, 1999
    Date of Event
    January 6, 1999
    Report Date
    February 9, 1999
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLIENT WAS SEATED AT THE BIODEX CABLE COLUMN DOING LATERAL PULL-DOWN BEHIND HIS HEAD. THE CABLE BROKE AND THE MOMENTUM OF THE BAR CAUSED IT TO STRIKE THE CLIENT IN THE HEAD. PT TO ER TO BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODEX CABLE COLUMN GCJ BIODEX MEDICAL SYSTEMS, INC. 940-200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other