BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSTEM, ISOKINETIC TESTING AND EVALUATION

    MDR report key: 1603398 · Received November 6, 2009

    Report

    Report Number
    2431314-2009-00001
    Event Type
    Other
    Date Received
    November 6, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 6, 2009
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    IKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE ADVISES THE WEEKLY INSPECTION OF WEIGHT STACK CABLE FOR WEAR OR DAMAGE. INITIAL INCIDENT REPORTED THE CABLE END TERMINATION COVER DETERIORATED. WE OUT-LINED THE INSPECTION PROCESS IN OUR INSTRUCTION MANUAL. THE USER SHOULD ADHERE TO THE MANUFACTURER'S REQUIREMENTS. THE WEIGHT STACK CABLE DID NOT BREAK. NO PICTURES WERE PROVIDED TO BIODEX. TALKING TO BIOMED THE PLASTIC COVER ON THE CABLE APPEARS TO HAVE DETERIORATED EXPOSING THE METAL LOOP SUPPORT RING AND THE METAL END OF THE LOOP RING CAUSED AN ABRASION TO THE PT. BASED ON OUR CONVERSATION WITH THE HOSPITAL BIOMED DEPARTMENT, THEY WILL REPLACE THE ORIGINAL DETERIORATED CABLE.

    Description of Event or Problem · 1

    EVENT DESC: THE PT WAS IN OUT-PATIENT REHAB COMPLETING AN EXERCISE ON A CABLE COLUMN. THE CABLE SUPPORT RING THAT COVERED THE LINK BETWEEN THE CABLE AND THE PT HANDLE BROKE AND EXPOSED A METAL EDGE. THE PT RECEIVED A SKIN TEAR FROM THE EXPOSED BARB. THE AREA WAS CLEANED WITH ALCOHOL. BANDAID AND PRESSURE APPLIED. DEVICE USAGE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK BIODEX MEDICAL SYSTEMS, INC. 940-200

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other