BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 3223930 · Received July 5, 2013

    Report

    Report Number
    3008642652-2013-01757
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS DEFECTIVE) HAS BEEN CONFIRMED. UPON EVAL, THE RESPONSE BUTTON COVERS AND METALLIC DOMES WERE MISSING FROM BOTH RESPONSE BUTTONS. THE CAUSE FOR THE INABILITY TO ACTIVATE THE DEVICE IS THE MISSING METALLIC DOMES. THE ROOT CAUSE FOR THE DAMAGED RESPONSE BUTTONS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED RESPONSE BUTTONS. THE PT 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
    308244 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR