BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221471 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01745
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (WON'T POWER ON) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO POWER ON. A ROOT CAUSE INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ROOT CAUSE INVESTIGATION. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT'S SISTER CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR WOULD NOT WORKING. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300556 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR