BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4321219 · Received December 2, 2014

    Report

    Report Number
    3008642652-2014-04523
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 25, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    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 EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETTING) WAS CONFIRMED. AS RECEIVED, THE CHARGER WAS RESETTING ON STARTUP. UPON EVALUATION, THERE WAS LIQUID CONTAMINATION ON THE BATTERY BOARD AND THE Q1 CURRENT CONTROLLING TRANSISTOR WAS INTERNALLY SHORTED ON THE BEDSIDE BOARD. THE CAUSE OF THE RESETS IS THE CONTAMINATED BATTERY BOARD AND INTERNALLY SHORTED Q1 COMPONENT. THE ROOT CAUSE OF THE CONTAMINATION IS LIKELY LIQUID INGRESS. THE ROOT CAUSE OF THE INTERNALLY SHORTED COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FORM THE CONTAMINATED BOARD OR SHORTED COMPONENT.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED CHARGER/MODEM SN (B)(4) INDICATING THAT IT WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776343 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA