BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061701 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00884
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 28, 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CANNOT COMPLETE BASELINE) WAS CONFIRMED. AS RECEIVED, THE MONITOR WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. UPON FURTHER EVALUATION, HOWEVER, THE MONITOR FAILED TO SUPPLY BELT NODE POWER. THE CAUSE OF THE INABILITY TO BASELINE IS INTERMITTENT ABILITY TO SUPPLY BELT NODE POWER. THE CAUSE OF THE INTERMITTENT ABILITY TO SUPPLY BELT NODE POWER IS A DEFECTIVE INVERTING CHARGE PUMP COMPONENT U612. THE CAUSE OF THE DEFECTIVE U612 CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U612. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A TERRITORY MANAGER (TM) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ATTEMPTING TO FIT A PATIENT TO REPORT THAT THE BASELINE SETUP COULD NOT BE COMPLETED. THE PATIENT WAS FIT WITH A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131107 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA