BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 3173255 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01511
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 4, 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 BAD) HAS BEEN CONFIRMED. UPON EVALUATION, THE METALLIC DOME IN BOTH RESPONSE BUTTONS WAS DAMAGED. THE CAUSE OF BAD RESPONSE BUTTONS IS THE DAMGE TO THE METALLIC DOMES. THE ROOT CAUSE FOR THE DAMAGED METALLIC DOMES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE, AS THE MONITOR'S CASE SHOWED SIGNS OF DAMAGE UPON RECEIPT. NO ADVERSE EVENT RESULTED FROM THE DAMAGED RESPONSE BUTTONS. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT'S DAUGHTER CONTACTED ZOLL TO REPORT THAT THE RESPONSE BUTTONS ON THE PATIENT'S MONITOR WERE NOT FUNCTIONING. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253545 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR