BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2890845 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-02999
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    H3 DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN 58002089 HAS BEEN COMPLETED. AS RECEIVED, THERE WERE BATTERY CHARGER FAULTS WHILE A TEST BATTERY WAS CHARGING. THE CAUSE OF THE FAULTS IS CONTAMINATION ON THE BATTERY BOARD INSIDE THE CHARGER/MODEM. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY LIQUID INGRESS OF AN UNKNOWN CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT FOR DOWNLOAD ISSUES. DURING SERVICING OF THE PATIENT'S CHARGER/MODEM, A REPORTABLE ISSUE WAS DISCOVERED. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR