BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4821617 · Received June 3, 2015

    Report

    Report Number
    3008642652-2015-03574
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 13, 2015
    Report Date
    June 1, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETTING) WAS CONFIRMED. AS RECEIVED, THE BATTERY CHARGER/MODEM WAS RESETTING. UPON EVAL, THERE WAS LIQUID CONTAMINATION ON THE BATTERY BOARD AND THE CURRENT CONTROLLING TRANSISTOR Q1 AND THE U13 CMOS FLASH MICROCONTROLLER WERE INTERNALLY SHORTED ON THE CHARGER BEDSIDE BOARD. THE CAUSE FOR THE FAILURE WAS ISOLATED TO THE CONTAMINATED BATTERY BOARD AND INTERNALLY SHORTED COMPONENTS. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNK LIQUID. THE ROOT CAUSE OF THE INTERNALLY SHORTED COMPONENTS WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT BATTERY CHARGER/MODEM SN (B)(4) WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357619 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA