BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3812727 · Received April 25, 2014

    Report

    Report Number
    3008642652-2014-01297
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (WON'T POWER UP) WAS CONFIRMED. AS REC'D, THE MONITOR FAILED THE INCOMING FUNCTIONAL TESTING AND WAS RESETTING AT THE BLUE SPLASH SCREEN. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ROOT CAUSE INVESTIGATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT REC'D A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WAS MAKING A LOUD STEADY TONE AND WAS REPEATEDLY RESETTING AT THE START-UP SCREEN. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251105 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR