BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4171162 · Received September 19, 2014

    Report

    Report Number
    3008642652-2014-02948
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 18, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (FAILED INCOMING TESTING) WAS CONFIRMED. UPON EVAL, THE MONITOR DISPLAYED SERVICE CODE 203 (PULSE TEST FAILURE) DURING TESTING. THE CAUSE FOR THE FAILURE WAS ISOLATED TO DEFECTIVE INDUCTORS T2 AND T3 ON THE MONITOR DEFIBRILLATOR BOARD. THE ROOT CAUSE FOR THE DEFECTIVE INDUCTORS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT MONITOR SN (B)(4) WAS UNABLE TO COMPLETE INCOMING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581504 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA