BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3002512 · Received February 15, 2013

    Report

    Report Number
    3008642652-2013-00438
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 12, 2013
    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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT OR CHECK BELT MESSAGES) WAS CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED THE HIPOT AND FALLOFF TESTS. THE CAUSE WAS AN OPEN ORANGE WIRE (LEAD 2-) IN THE DISTRIBUTION NODE (DN) TO ECG C AND D CABLE. THE WIRE WAS OPEN IN BETWEEN ECG C AND D. THE OPEN WIRE CAUSED THE REPORTED CHECK ELECTRODE BELT MESSAGES. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT SEVERAL ADJUST BELT OR CHECK BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66254 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR