BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3940375 · Received April 17, 2014

    Report

    Report Number
    3008642652-2014-01147
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK BELT MESSAGES) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THERE WAS NO VISIBLE DAMAGE TO THE CABLE, BUT A DAMAGED PULSE WIRE WAS FOUND IN THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND REAR THERAPY ELECTRODE (TE) AT THE J2 TAB OF THE REAR TE. THE CAUSE OF THE CHECK BELT MESSAGES AND INCOMING TEST FAILURE IS THE OPEN PULSE WIRE. THE ROOT CAUSE OF THE OPEN WIRE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. PATIENT WAS RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT CHECK BELT ALARMS. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236055 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR