BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221461 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01763
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 28, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT MESSAGES, DAMAGED WIRE) HAS BEEN CONFIRMED. AS RECEIVED, THE ELECTRODE BELT CONNECTOR RECEPTACLE WAS DAMAGED AND THE WHITE PULSE WIRE OF THE BELT CONNECTOR ASSEMBLY WAS SEVERED. THE CAUSE OF THE ADJUST BELT MESSAGES IS THE SEVERED WHILE PULSE WIRE. THE CAUSE OF THE SEVERED WHITE PULSE WIRE AND DAMAGED CONNECTOR RECEPTACLE CANNOT BE POSITIVELY IDENTIFIED BUT IT IS LIKELY DUE TO PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED PULSE WIRE. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT ADJUST BELT MESSAGES AND A DAMAGED WHITE WIRE NEAR THE ELECTRODE BELT RECEPTACLE. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300657 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR