BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3961222 · Received May 28, 2014

    Report

    Report Number
    3008642652-2014-01597
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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 (SERVICE CODE 204) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR FAILED THE CURRENT TEST AND WAS UNABLE TO COMMUNICATE WITH A MONITOR. UPON INVESTIGATION THE U713 MICROCONTROLLER WAS FOUND TO BE INTERNALLY SHORTED ON THE DISTRIBUTION NODE PCA, CAUSING THE INABILITY TO COMMUNICATE AND THE TEST FAILURE. THE ROOT CAUSE FOR THE SHORTED U713 COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVEN RESULTED FROM DEFECTIVE U713. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING SERVICE CODE 204 (BELT/MONITOR UNUSABLE). THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314689 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR