BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000

    MDR report key: 3112100 · Received May 3, 2013

    Report

    Report Number
    3008642652-2013-01175
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE ELECTRODE BELT FAILED INCOMING TESTING. THE CAUSE OF THE TEST FAILURE HAS BEEN ISOLATED TO COMPONENTS U727 AND U728, INPUT LOGIC TRANSLATORS, ON THE PCA BOARD SN (B)(4). BOTH COMPONENTS WERE SHORTED. THE ROOT CAUSE OF THE SHORTED COMPONENTS WAS UNABLE TO BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE SHORTED COMPONENTS. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT FOR AN UNRELATED EVENT. UPON SERVICING OF THE ELECTRODE, A REPORTABLE PROBLEM WAS DISCOVERED. THE ELECTRODE BELT FAILED INCOMING TESTING. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193483 LIFEVEST WCD 4000 WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR