BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2800163 · Received October 12, 2012

    Report

    Report Number
    3008642652-2012-02695
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 2, 2012
    Report Date
    October 8, 2012
    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 SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS NOT WORKING) WAS CONFIRMED. UPON INVESTIGATION, THE FRONT AND REAR RESPONSE BUTTONS WERE NOT FUNCTIONING. EVIDENCE OF MOISTURE WAS DISCOVERED INSIDE THE RESPONSE BUTTONS. THE ROOT CAUSE FOR THE DEFECTIVE RESPONSE BUTTONS WAS INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. 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 BUTTONS WEREN'T ACTIVATING HER MONITOR. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR