BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4172835 · Received September 19, 2014

    Report

    Report Number
    3008642652-2014-02961
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 29, 2004
    Report Date
    September 19, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DISPLAYS ERROR CODE WHEN CHARGING A BATTERY PACK) WAS CONFIRMED. AS RECEIVED, THE CHARGER WAS UNABLE TO CHARGE A BATTERY PACK. UPON INVESTIGATION, THE Q1 TRANSISTOR WAS INTERNALLY SHORTED. THE CAUSE OF THE INABILITY TO CHARGE A BATTERY PACK IS THE SHORTED TRANSISTOR. THE ROOT CAUSE OF THE SHORTED COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM.

    Description of Event or Problem · 1

    A U.S. DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT CHARGER/MODEM SN (B)(4) WAS DISPLAYS ERROR CODE WHEN CHARGING A BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582987 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA