BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3210027 · Received June 27, 2013

    Report

    Report Number
    3008642652-2013-01696
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) IS UNDERWAY. THE REPORTED PROBLEM (WON'T POWER UP) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS INTERMITTENTLY RESETTING. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ROOT CAUSE ANALYSIS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE MONITOR WAS NOT IN USE BY A PATIENT.

    Description of Event or Problem · 1

    A ZOLL PATIENT SERVICE REPRESENTATIVE CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A MONITOR WOULD NOT POWER UP. THE MONITOR WAS NOT IN USE BY A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293352 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA