BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3960572 · Received June 20, 2014

    Report

    Report Number
    2520313-2014-00036
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    MWI
    PMA / PMN Number
    K042569
    Removal / Correction Number
    Z-0810-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON JUNE 18, 2014, BAYER R AND I SERVICE REPLACED THE SYSTEM MAINBOARD AT THE SITE AND CONFIRMED SYSTEM FUNCTIONALITY. ON NOVEMBER 21, 2013, BAYER HEALTHCARE DISTRIBUTED A FIELD SAFETY NOTICE RECALLING MAIN BOARDS WITH PART NUMBER 301641 THAT WERE INSTALLED IN SOME MEDRAD VERIS MR VITAL SIGNS MONITORS. THESE MAIN BOARDS ARE BEING RECALLED DUE TO THE POTENTIAL FOR UNEXPECTED SHUTDOWN OF THE SYSTEM WHILE IN USE.

    Description of Event or Problem · 1

    SUBSEQUENT TO RECEIPT OF THE FIELD SAFETY NOTICE, THE SITE REPORTED THE FOLLOWING: THE VERIS MONITOR SHUT OFF DURING A SEDATION CASE. THE POWER WAS RESTORED WHEN THE "ON" BUTTON WAS DEPRESSED. THE PT EXAM WAS COMPLETED WITHOUT EVENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363708 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PT MWI BAYER MEDICAL CARE, INC. 3011994W

    Patients

    Seq Age Sex Outcome Treatment
    1