BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 400 SYSTEM

    MDR report key: 3191049 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01630
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 (CODE 24) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE TRUNK CABLE CONNECTOR WAS PULLED FROM THE TRUNK CABLE OF THE ELECTRODE BELT, CAUSING ALL THE WIRES TO OPEN IN THE TRUNK CABLE CONNECTOR. THE CAUSE OF THE CODE 204 WAS THE DAMAGED WIRES. THE ROOT CAUSE OF THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT'S MOTHER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SVC CODE 204 - BELT/MONITOR UNUSABLE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283187 LIFEVEST WCD 400 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR