BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4080962 · Received July 9, 2014

    Report

    Report Number
    3008642652-2014-02127
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 8, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 (NOT DETECTING BATTERY PACKS) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE BATTERY CHARGER WOULD NOT CHARGE A BATTERY PACK. THE CAUSE FOR THE INABILITY TO CHARGE WAS ISOLATED TO A SHORTED U13 CMOS FLASH MICROCONTROLLER ON THE BEDSIDE BOARD. THE ROOT CAUSE FOR THE SHORTED COMPONENT WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER WAS NOT DETECTING INSERTED BATTERY PACKS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400702 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR