BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1961457 · Received January 10, 2011

    Report

    Report Number
    3002158293-2011-00023
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 7, 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 (ADJUST/CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON INSPECTION, THE BELT WAS FOUND TO HAVE DAMAGED CABLE. THE CABLE RUNNING FROM ECG B TO THE DISTRIBUTION NODE (DN) WAS FOUND TO HAVE AN ELECTRICAL SHORT BETWEEN THE SHIELDING AND WIRES. THE INTERNAL SHORT CAUSED THE CHECK BELT MESSAGES. THE ROOT CAUSE OF THE SHORTED LINE CANNOT BE POSITIVELY IDENTIFIED. ONCE THE CABLE WAS REPLACED, THE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE INTERNAL SHORT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A TERRITORY MANAGER (TM) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT IS RECEIVING CONSTANT CHECK/ADJUST BELT MESSAGES. THE PT WAS FIT TO THE DEVICE THE DAY PRIOR. THE TM ATTEMPTED TO TROUBLESHOOT THE PROBLEM TO NO AVAIL. 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 76 YR