BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2082171 · Received April 28, 2011

    Report

    Report Number
    3002158293-2011-00469
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 26, 2011
    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 (DAMAGED RESPONSE BUTTONS) HAS BEEN CONFIRMED. UPON RECEIPT, BOTH RESPONSE BUTTON COVERS WERE MISSING. ADDITIONALLY, THE FRONT RESPONSE DOME WAS MISSING CAUSING THE FRONT RESPONSE BUTTON NOT TO FUNCTION. THE CAUSE FOR THE DAMAGED RESPONSE BUTTONS CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE INOPERATIVE RESPONSE BUTTON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS RESPONSE BUTTONS FELL OFF. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR