BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3842555 · Received February 21, 2014

    Report

    Report Number
    3008642652-2014-00448
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 20, 2014
    Report Date
    February 14, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 (BATTERY CHARGER FAULTS) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER WAS UNABLE TO CHARGE A BATTERY PACK. UPON EVALUATION, THERE WAS CONTAMINATION ON THE BATTERY BOARD CONTACTS. THE CAUSE OF THE FAULTS AND INABILITY TO CHARGE THE BATTERIES IS THE CONTAMINATION ON THE BOARD CONTACTS. THE CAUSE OF THE CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BOARDS. THE PT RECEIVED REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6) MALE PT TO EXCHANGE HIS CHARGER/MODEM. THE PT'S DOWNLOADED DATA REVEALED RECURRING BATTERY CHARGER FAULTS. THE PT WAS PROVIDED WITH A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109432 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR