BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2800116 · Received October 12, 2012

    Report

    Report Number
    3008642652-2012-02700
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 9, 2012
    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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (GONG ALARMS) HAS BEEN CONFORMED. UPON EVAL, THE +5V LINE IN THE TRUNK CABLE WAS OPEN NEAR THE TRUNK CABLE CONNECTOR. THE CAUSE OF THE GONG ALARMS IS INTERMITTENT CHANNEL DISTORTION. THE CAUSE OF THE INTERMITTENT CHANNEL DISTORTION IS THE OPEN +5V LINE. THE ROOT CAUSE OF THE OPEN +5V LINE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE ON THE TRUNK CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT GONG ALARMS. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR