BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2212051 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00178
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 8, 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 ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DEVICE DISABLED ALARM) HAS BEEN CONFIRMED. THE CAUSE OF THE DEVICE DISABLED ALARM IS DUE TO A BROKEN INTERNAL CABLE WIRE CONNECTING THE DISTRIBUTION NODE (DN) TO ECG C&D. THE CAUSE OF THE BROKEN CABLE WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO MECHANICAL STRESS. THE ROOT CAUSE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A "DEVICE DISABLED" MESSAGE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    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 65 YR