BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6184602 · Received December 18, 2016

    Report

    Report Number
    3008642652-2016-09263
    Event Type
    Malfunction
    Date Received
    December 18, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 15, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR RESET 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 THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED A MONITOR INDICATING THAT IT WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835116 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1