BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3539023 · Received November 5, 2013

    Report

    Report Number
    3008642652-2013-03112
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    October 10, 2013
    Report Date
    October 24, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMERY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT/CHECK BELT MESSAGES) WAS CONFIRMED. UPON EVALUATION, THE ELECTRODE BELT SN (B)(4) FAILED INCOMING FUNCTIONAL TESTING. THE CAUSE FOR THE TEST FAILURES WAS ISOLATED TO CORROSION FOUND ON PINS 1, 3, 4, AND 5 OF THE U1 COMPONENT OF ECG CABLE 'B'. THE ROOT CAUSE FOR THE CORROSION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF CONTAMINATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HEW AS RECEIVING ADJUST BELT/CHECK BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571008 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR