BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5141556 · Received October 9, 2015

    Report

    Report Number
    3008642652-2015-06274
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 22, 2015
    Report Date
    October 7, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE MONITOR WAS RESETTING DURING PULSE TESTING. THE ROOT CAUSE FOR THE RESETS WAS ISOLATED TO NOISE FROM THE DEFIBRILLATOR PCA HIGH-VOLTAGE CAPACITORS PROPAGATING ON THE MAIN BATTERY WIRE ON THE MONITOR C/A BOARD. A PMA SUPPLEMENT (P010030/S064) FOR A DESIGN CHANGE TO ADDRESS THIS ISSUE WAS CONSIDERED APPROVABLE BY FDA ON 09/11/2015. NO ADVERSE EVENT RESULTED FROM RESETS.

    Description of Event or Problem · 1

    DURING SERVICING OF A MONITOR WHICH WAS RETURNED FOR AN UNRELATED PROBLEM, A REPORTABLE MALFUNCTION WAS DISCOVERED. THE MONITOR WAS RESETTING DURING PULSE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670756 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1