BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3982849 · Received June 13, 2014

    Report

    Report Number
    3008642652-2014-01774
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 PROBLEM) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER WAS UNABLE TO CHARGE A BATTERY PACK. UPON EVAL, THE Q1 TRANSISTOR WAS SHORTED. THE CAUSE OF THE INABILITY TO CHARGE THE BATTERIES IS THE SHORTED Q1 TRANSISTOR. THE ROOT CAUSE OF THE SHORTED COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED COMPONENT. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    THE SON OF AN (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT AND REPORTED A BATTERY CHARGER PROBLEM. PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350784 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR