BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173275 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01529
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 6, 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 (CODE 204) HAS BEEN CONFIRMED. UPON EVALUATION, THE TRUNK CABLE WAS PULLED FROM THE STRAIN RELIEF AND THE J702 CONNECTOR (TRUNK CABLE CONNECTOR) WAS LIFTED OFF OF THE PAD INSIDE THE DISTRIBUTION NODE. THE CAUSE OF THE CODE 204 IS A DISRUPTION IN COMMUNICATION BETWEEN THE ELECTRODE BELT AND MONITOR. THE CAUSE OF THE DISRUPTION IN COMMUNICATION IS THE DAMAGED J702 CONNECTOR. THE ROOT CAUSE FOR THE DAMAGED J702 CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 204. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253638 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR