BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3033161 · Received March 1, 2013

    Report

    Report Number
    3008642652-2013-00596
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE MONITOR FAILED THE INCOMING PULSE TEST. THE MONITOR FIRED A 189.9 J NEGATIVE MONO-PHASIC PULSE DURING THE DETECT AND TREAT SEQUENCE. HOWEVER, THE UNIT WAS ABLE TO FIRE A SINGLE 150J PULSE DURING THE COMMUNICATION TEST SYSTEM PULSE TEST. THE MONO-PHASIC PULSE IS SUSPECTED TO BE CAUSED BY A FAULTY DEFIBRILLATOR CONTROL MODULE; HOWEVER, THE ROOT CAUSE INVESTIGATION WAS UNABLE TO BE COMPLETED, DUE TO OBSOLESCENCE OF DEVICE COMPONENTS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT WAS NOT ISSUED A REPLACEMENT MONITOR AS THE PATIENT ENDED USE.

    Description of Event or Problem · 1

    WHILE INVESTIGATING A (B)(6) MALE PATIENT'S MONITOR FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE MONITOR FIRED A 189.9J NEGATIVE MONOPHASIC PULSE. THE PATIENT WAS NOT ISSUED A REPLACEMENT MONITOR AS THE PATIENT ENDED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90285 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR