BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2221466 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00454
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 12, 2011
    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 ARE NOT WORKING) HAS BEEN CONFIRMED. UPON INSPECTION, IT WAS DISCOVERED THAT THE FRONT RESPONSE BUTTON FLEX CIRCUIT WAS PINCHED, CAUSING THE RESPONSE BUTTON TO BE INTERMITTENT. THE ROOT CAUSE OF THE PINCHED FLEX CIRCUIT WAS DUE TO AN ASSEMBLY ERROR. NO ADVERSE EVENT RESULTED FROM THE INOPERATIVE RESPONSE BUTTON. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS RESPONSE BUTTONS WERE NOT BLINKING. THE PT ALSO MENTIONED HE HAD TO PRESS THE RESPONSE BUTTONS SEVERAL TIMES TO ACTIVATE THE DEVICE. 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 59 YR