BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983694 · Received June 25, 2014

    Report

    Report Number
    3008642652-2014-01924
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETTING) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS RESETTING. THE CAUSE FOR THE RESETS WAS ISOLATED TO A SHORTED Q1 CURRENT-CONTROLLING TRANSISTOR ON THE BEDSIDE PCA BOARD. THE ROOT CAUSE FOR THE SHORTED Q1 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT BATTERY/CHARGER/MODEM.

    Description of Event or Problem · 1

    THE DAUGHTER OF A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERY CHARGER WAS RESETTING. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371417 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR