BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3844876 · Received March 12, 2014

    Report

    Report Number
    3008642652-2014-00801
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 11, 2014
    Manufacturer
    ZOLL LIFECOR 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 EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK BELT ALARMS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR HAD NO DRIVEN GROUND SIGNAL, CAUSING THE REPORTED CHECK BELT ALARMS. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN DRIVEN GROUND RESISTOR R781 ON THE MONITOR C/A BOARD. THE ROOT CAUSE FOR THE OPEN RESISTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN RESISTOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING FREQUENT CHECK BELT ALARMS. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149700 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR