BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961250 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00206
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 18, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE MONITOR WAS RESETTING DURING PULSE TESTING. THE CAUSE OF THE RESETS IS A DEFECTIVE U1 SWITCHING REGULATOR COMPONENT. THE ROOT CAUSE OF THE DEFECTIVE U1 COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U1 COMPONENT. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6) FEMALE PT FOR AN UNRELATED ISSUE. DURING SERVICING OF THE PT'S MONITOR, A REPORTABLE PROBLEM WAS DISCOVERED. THE MONITOR WAS RESETTING DURING PULSE TESTING. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28469 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR