BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1781318 · Received July 28, 2010

    Report

    Report Number
    3002158293-2010-00786
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS WILL NOT START THE SYSTEM) HAS BEEN CONFIRMED. THE CAUSE OF THE RESPONSE BUTTONS NOT POWERING ON THE SYSTEM WAS DUE TO A DEFECTIVE FRONT RESPONSE BUTTON. THE CAUSE OF THE DEFECTIVE RESPONSE BUTTON WAS A CRACKED CONDUCTOR ON THE FLEX CIRCUIT TAIL. THE ROOT CAUSE APPEARS TO BE AN ASSEMBLY ERROR. THE FLEX CIRCUIT WAS INADVERTENTLY CREASED BENEATH THE DISPLAY ENCLOSURE. 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 CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT SERVICE TO REPORT THE RESPONSE BUTTONS ARE STUCK AND THE DEVICE KEEPS REPEATING "TO ACTIVATE DEVICE, PRESS RESPONSE BUTTONS". THE PT WAS PROVIDED WITH 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 44 YR