BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2319578 · Received October 21, 2011

    Report

    Report Number
    3008642652-2011-00851
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 9, 2011
    Report Date
    October 20, 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 EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS RESETTING AND WASN'T ABLE TO FULLY POWER UP. THE CAUSE OF THE MONITOR RESETTING WAS A DEFECTIVE PROGRAMMABLE LOGIC DEVICE (PLD) AND PXA PROCESSING CHIP ON THE C/A BOARD. THE ROOT CAUSE OF THE DEFECTIVE PLD AND PXA CHIPS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE PLD AND PXA CHIPS. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) OLD MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WOULD NOT POWER UP. THE PATIENT 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 35 YR