BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3810157 · Received February 4, 2014

    Report

    Report Number
    3008642652-2014-00376
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    December 22, 2013
    Report Date
    February 3, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 NOT WORKING) WAS CONFIRMED. UPON INVESTIGATION THE REAR RESPONSE BUTTON WAS NON-FUNCTIONAL. THE ROOT CAUSE FOR THE NON-FUNCTIONAL RESPONSE BUTTON WAS AN INTERMITTENT CONNECTION IN THE RESPONSE BUTTON FLEX CIRCUIT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER MONITOR RESPONSE BUTTONS WERE NOT WORKING. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73518 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR