BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3940391 · Received April 17, 2014

    Report

    Report Number
    3008642652-2014-01146
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 10, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS DO NOT WORK) WAS CONFIRMED. AS RECEIVED, THE RESPONSE BUTTONS WERE INTERMITTENT. THE CAUSE FOR THE INABILITY TO ACTIVATE THE DEVICE IS THE INTERMITTENT RESPONSE BUTTONS. THE CAUSE OF THE INTERMITTENT RESPONSE BUTTON IS A DAMAGED CONTACT AT THE FRONT RESPONSE BUTTON. THE ROOT CAUSE FOR THE DAMAGED CONTACT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONTACT. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE RESPONSE BUTTONS WOULD NOT ACTIVATE THE DEVICE. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235818 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR