BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FL-601-97

    MDR report key: 817141 · Received February 2, 2007

    Report

    Report Number
    1056553-2007-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    January 4, 2007
    Report Date
    January 30, 2007
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    PMA / PMN Number
    K971968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REGARDING THIS CABLE INDICATED THAT THE WIRE WAS NOT PROPERLY PREPPED PRIOR TO THE SECONDARY SOLDER OPERATION. ALL OF REMINGTON MEDIAL, INC. CABLES ARE 100% TESTED FOR CONTINUITY AND FOR HIPOT. THE CONNECTION ON THIS CABLE WAS EVIDENTLY INTACT WHEN IT WAS INSPECTED BY OUR FINAL INSPECTION GROUP AND OUR FINAL QA RELEASE. ALL EMPLOYEE INVOLVED IN THIS OPERATION PARTICIPATED IN THE OVERALL ROOT CAUSE ANALYSIS AND HAVE UNDERGONE ADDITIONAL TRAINING.

    Description of Event or Problem · 1

    PATIENT WAS CONNECTED TO OUR FL-601-97 EXTENSION CABLE. HOSPITAL PERSONNEL NOTICED THAT THE END OF THE CABLE CONNECTED TO THE PATIENT'S LEAD WAS DISCONNECTED FROM THE SCREW TIGHT CHUCK. THE CABLE WAS IMMEDIATELY REPLACED; THEIR WAS NO CHANGE IN THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FL-601-97 DISPOSABLE EXTENSION CABLE DSA REMINGTON MEDICAL, INC. FL-601-97 0624413

    Patients

    Seq Age Sex Outcome Treatment
    1 *