BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2974597 · Received January 29, 2013

    Report

    Report Number
    3008642652-2013-00195
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER RESETTING) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS RESETTING. THE CAUSE FROM THE RESETS WERE ISOLATED TO CORRUPT PROGRAMMING OF THE FLASH MEMORY ON THE PCA BOARD. AFTER REPROGRAMMING THE PCA BOARD, THE BATTERY CHARGER/MODEM WAS FULLY FUNCTIONAL. THE ROOT CAUSE FOR THE CORRUPT PROGRAMMING COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT PROGRAMMING. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER/MODEM WAS NOT RESPONDING. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39911 LIFEVEST WCD 4000 SYSTEM WEARABLE CARIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR