BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843821 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02871
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 25, 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 FRONT RESPONSE BUTTON WAS NOT WORKING, WHICH PREVENTED THE MONITOR FROM POWERING UP PAST THE SPLASH SCREEN. THE ROOT CAUSE FOR THE DEFECTIVE FRONT RESPONSE BUTTON SWITCH COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON. THE LAST PATIENT TO USE THE MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, THE FRONT RESPONSE BUTTON ON MONITOR SN (B)(4) WAS NOT WORKING. 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 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA