BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2953949 · Received January 15, 2013

    Report

    Report Number
    3008642652-2013-00080
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 23, 2012
    Report Date
    January 8, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ACTIVATE DEVICE) HAS BEEN CONFIRMED. UPON EVALUATION, THE RESPONSE BUTTONS WERE NON-RESPONSIVE. THE CAUSE FOR THE INABILITY TO ACTIVATE THE DEVICE IS THE NON-RESPONSIVE RESPONSE BUTTONS. THE CAUSE FOR THE NON-RESPONSIVE RESPONSE BUTTON IS A DETACHED CABLE AT THE REAR RESPONSE BUTTON. THE ROOT CAUSE OF THE DETACHED CABLE CANNOT BE POSITIVELY IDENTIFIED BUT MAY HAVE BECOME DISLODGED DURING PHYSICAL IMPACT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE RESPONSE BUTTONS WILL NOT ACTIVATE THE DEVICE. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21893 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR