BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2821940 · Received September 28, 2012

    Report

    Report Number
    3008642652-2012-02423
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 25, 2012
    Report Date
    September 13, 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 BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CANNOT BE RECOGNIZED) HAS BEEN CONFIRMED. UPON EVAL, THE BELT FAILED THE CURRENT AND FALL-OFF TESTS. THE CAUSE OF THE INABILITY TO THE RECOGNIZED AND THE CAUSE OF THE TEST FAILURES IS SLOW TIMING FOR COMMUNICATION WITH THE MONITOR. THE CAUSE FOR THE SLOW TIMING IS ANY DEFECTIVE MSP 430 16-BIT LOW POWER MCU COMPONENT U713. THE CAUSE OF THE DEFECTIVE U713 IS AN IMPROPER OUTPUT AT PIN 55. THE ROOT CAUSE OF THE IMPROPER OUTPUT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PT SVC REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BELT COULD NOT BE RECOGNIZED BY THE PT'S MONITOR. 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 76 YR