BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KUFEVEST WCD 3100 SYSTEM

    MDR report key: 3012655 · Received February 22, 2013

    Report

    Report Number
    3008642652-2013-00426
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 11, 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 EVAL: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS NOT WORKING) WAS CONFIRMED. UPON INVESTIGATION, THE METAL SWITCH WAS MISSING FROM THE REAR RESPONSE BUTTON. THE ROOT CAUSE FOR THE DAMAGED RESPONSE BUTTON COULD NOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR RESPONSE BUTTON. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER RESPONSE BUTTON FELL OFF AND WOULD NOT ACTIVATE THE MONITOR. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78552 KUFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR