BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823816 · Received May 2, 2014

    Report

    Report Number
    3008642652-2014-01324
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 28, 2014
    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. AS RECEIVED, THE MONITOR FAILED INCOMING PULSE TESTING. UPON EVALUATION, THE Q10 COMPONENT WAS DEFECTIVE ON THE DEFIBRILLATOR BOARD. THE CAUSE OF THE INCOMING PULSE TEST FAILURE IS THE DEFECTIVE Q10 COMPONENT. THE ROOT CAUSE OF THE DEFECTIVE COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, MONITOR SN (B)(4) FAILED INCOMING PULSE TESTING. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264871 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA