BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2212039 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00164
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 7, 2011
    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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. UPON EVALUATION CORROSION WAS DISCOVERED ON THE AUXILLIARY BOARD AT J2005, J2007 AND J2008, PREVENTING THE MONITOR FROM POWERING ON. THE ROOT CAUSE FOR THE CORROSION CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF LIQUID INGRESS WITHIN THE MONITOR. NO ADVERSE EVENT RESULTED FROM THE CORROSION. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE SON OF A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WOULD NOT POWER ON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    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 76 YR