BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2841360 · Received October 23, 2012

    Report

    Report Number
    3008642652-2012-02825
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 23, 2012
    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 SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE MONITOR WAS FOUND TO HAVE BURNT TRACES AND DAMAGED COMPONENTS ON THE DEFIBRILLATOR BOARD. THE CAUSE OF THE INABILITY TO POWER ON WAS THE BURNT TRACES AND DAMAGED COMPONENTS. THE BURNT TRACES WERE CAUSED BY THE DAMAGED COMPONENTS. THE ROOT CAUSE OF THE DAMAGED COMPONENTS WAS ABLE TO BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO MECHANICAL SHOCK FROM PHYSICAL IMPACT. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRACES. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICING MONITOR SN (B)(4), THE MONITOR WAS UNABLE TO POWER ON. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA