BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1845042 · Received September 10, 2010

    Report

    Report Number
    3002158293-2010-00924
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 4, 2010
    Report Date
    September 10, 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 MANUFACTURE DATE: MONITOR SN (B)(4) : (B)(6) 2009, BATTERY PACK SN (B)(4) : (B)(6) 2008. DEVICE EVALUATION SUMMARY: EVALUATIONS OF MONITOR SN (B)(4) AND BATTERY SN (B)(4) HAVE BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR IS UNABLE TO POWER ON) HAS BEEN CONFIRMED. THE CAUSE OF THE MONITOR NOT POWERING ON WAS DUE TO CORROSION ON COMPONENT (B)(4) , WHICH HAD CAUSED THE ISP LINE TO BE SHORTED TO GROUND, PREVENTING THE UNIT FROM POWERING ON. THE ROOT CAUSE OF THE CORRODED AUXILIARY BOARD CANNOT BE DETERMINED, BUT WAS LIKELY DUE TO LIQUID INGRESS THROUGH THE AUXILIARY PORT. BATTERY SN (B)(4) WAS UNABLE TO HOLD ITS FULL CHARGE CAPACITY. THE ROOT CAUSE OF THE BATTERY NOT BEING ABLE TO HOLD ITS FULL CHARGE CAPACITY CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR OR DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT'S DAUGHTER CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE BATTERY WAS JUST CHANGED AND NEW THE MONITOR WILL NOT POWER ON. THE PATIENT WAS PROVIDED WITH A REPLACEMENT MONITOR AND BATTERY PACK.

    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 79 YR