BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2953951 · Received January 15, 2013

    Report

    Report Number
    3008642652-2013-00111
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 22, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR COMING APART/ WILL NOT POWER ON) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. UPON EVALUATION, THE CASE AND END CAP WERE SEPARATED AND THE WHITE COMMUNICATION WIRE WAS DAMAGED AT THE J107 CONNECTOR. THE CAUSE FOR THE INABILITY TO POWER ON IS THE DAMAGED COMMUNICATION WIRE. THE ROOT CAUSE FOR THE DAMAGED COMMUNICATION WIRE IS THE PHYSICAL DAMAGE TO THE MONITOR CASE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CASE. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S DAUGHTER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WAS COMING APART AND WOULD NOT POWER ON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22187 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR