BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3973109 · Received June 5, 2014

    Report

    Report Number
    3008642652-2014-01732
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 204) WAS CONFIRMED. AS RECEIVED, AN OPEN WAS FOUND ALONG THE RED CAN H WIRE. 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 OPEN. THE ROOT CAUSE OF THE OPEN CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRUNK CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328616 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR