BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4972832 · Received August 5, 2015

    Report

    Report Number
    3008642652-2015-04836
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 10, 2015
    Report Date
    August 4, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM RESET. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A THERMALLY DAMAGED Q1 CURRENT-CONTROLLING TRANSISTOR AND A CORRUPTED U13 CMOS FLASH MICROCONTROLLER ON THE BEDSIDE PCA. IN ADDITION, THERE WAS LIQUID CONTAMINATION OF THE BATTERY BOARD. THE ROOT CAUSE FOR THE THERMALLY DAMAGED Q1 TRANSISTOR AND CORRUPTED U13 MICROCONTROLLER COULD NOT BE POSITIVELY IDENTIFIED. THE ROOT CAUSE FOR THE LIQUID CONTAMINATION WAS THE INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM SN (B)(4) AND REPORTED THAT THE BATTERY CHARGER/MODEM RESETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516958 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1