BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1894148 · Received November 5, 2010

    Report

    Report Number
    3002158293-2010-01166
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (EXPOSED WIRES) HAS BEEN CONFIRMED. THE CAUSE OF THE ARRHYTHMIA ALARMS WAS DUE TO A CUT IN THE CABLE FROM ECG C TO THE DISTRIBUTION NODE. THE DEFECTIVE CABLE CAUSED A FLAT LINE ON THE FB AND SS CHANNELS. THE ROOT CAUSE OF THE CUT IN THE CABLE CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY DUE TO EXCESSIVE FORCE. ONCE THE CABLE WAS REPLACED, THE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6 OLD MALE PATIENT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THERE WERE WIRES EXPOSED NEXT TO THE ELECTRODE WITH THE RED VELCRO. THE PATIENT'S ELECTRODE BELT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR