BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4031078 · Received July 17, 2014

    Report

    Report Number
    3008642652-2014-02249
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BELT SN (B)(4) HAS NOT YET BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT/CHECK BELT MESSAGES) IS BEING INVESTIGATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED FOLLOWING COMPLETION OF INVESTIGATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT. THE PT RECEIVED A REPLACEMENT BELT.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT ADJUST BELT AND CHECK BELT MESSAGES DURING PT SET-UP. PT'S BELT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420377 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA