BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4161329 · Received July 23, 2014

    Report

    Report Number
    3008642652-2014-02304
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED MONITOR CONNECTOR) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR BELT CONNECTOR WAS DAMAGED. THE CONNECTOR WAS DETACHED FROM THE CASE. THE ROOT CAUSE OF THE DAMAGED CONNECTOR EXCESSIVE FORCED PLACED AT THE CONNECTOR. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A DAMAGED MONITOR CONNECTOR. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430730 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR