BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3941327 · Received April 11, 2014

    Report

    Report Number
    3008642652-2014-01070
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 (RESETTING / WILL NOT RECOGNIZE BATTERY PACK) WAS CONFIRMED. AS RECEIVED, THE CHARGER WAS UNABLE TO CHARGE A BATTERY PACK. UPON EVALUATION, THE U13 8-BIT CMOS FLASH MICRO-CONTROLLER WAS SHORTED. THE CAUSE OF THE RESETS AND INABILITY TO RECOGNIZE THE BATTERIES IS THE SHORTED U13 COMPONENT. THE ROOT CAUSE OF THE SHORTED COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED COMPONENT. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CHARGER/MODEM WAS RESETTING AND WOULD NOT RECOGNIZE A BATTERY PACK. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220175 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR