BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2882112 · Received November 12, 2012

    Report

    Report Number
    3008642652-2012-02959
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 2, 2012
    Report Date
    November 5, 2012
    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 CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER NOT FUNCTIONING PROPERLY / SWITCHED BETWEEN CHARGING AND INSERT BATTERY) HAS BEEN CONFIRMED. THE CAUSE OF THE IMPROPERLY FUNCTIONING CHARGER/MODEM IS THE CONTAMINATION ON THE BATTERY BOARD INSIDE THE CHARGER/MODEM. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT IS LIKELY LIQUID INGRESS OF AN UNKNOWN CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CHARGER IS DISPLAYING "CHARGER PROBLEM" AND WILL NOT CHARGE THE BATTERY.

    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 64 YR