BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3957253 · Received June 17, 2014

    Report

    Report Number
    2520313-2014-00035
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    MWI
    PMA / PMN Number
    K042569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECALLED MAIN BOARDS WITH APRT NUMBER 301641 THAT WERE INSTALLED IN SOME MEDRAD VERIS MR VITAL SIGNS MONITORS. THESE MIN BOARDS ARE BEING RECALLED DUE TO THE POTENTIAL FOR UNEXPECTED SHUTDOWN OF THE SYSTEM WHILE IN USE.

    Description of Event or Problem · 1

    A BAYER R AND I REPRESENTATIVE REPORTED THE FOLLOWING: THE VERIS MOTOR SHUT DOWN AFTER THE FIRST FEW SCANS. THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354446 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI BAYER MEDICAL CARE, INC. 3011993W

    Patients

    Seq Age Sex Outcome Treatment
    1