BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080859 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-01032
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 (DAMAGED CONNECTOR) HAS BEEN CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE CONNECTOR WAS DAMAGED AND ORANGE (+5V) AND BROWN (-5V) WIRES WERE OPEN INSIDE OF THE CONNECTOR. THE ROOT CAUSE FOR THE OPEN WIRES AND DAMAGED CONNECTOR WAS PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR AND OPEN WIRES. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT WIRES WERE EXPOSED ON HER ELECTRODE BELT TRUNK CABLE CONNECTOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159886 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR