BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3961189 · Received May 28, 2014

    Report

    Report Number
    3008642652-2014-01598
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WAS FOUND TO BE CRACKED. UPON INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A PULLED TRUNK CABLE. THE TRUNK CABLE WAS PULLED FROM THE TRUNK CABLE CONNECTOR AND CONNECTOR J702 WAS PULLED FROM THE DISTRIBUTION NODE PCA. THE ROOT CAUSE FOR THE PULLED CABLE, PULLED CONNECTORS, AND DAMAGED TRUNK CABLE CONNECTOR WAS UNABLE TO BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE SON OF A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT WAS RECEIVING A SERVICE CODE 204 (BELT/MONITOR UNUSABLE). THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314922 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR