BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3909363 · Received February 24, 2014

    Report

    Report Number
    2520313-2014-00011
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 18, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    MHX
    Removal / Correction Number
    Z-0810-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R & I SERVICE REPLACED THE SYSTEM MAIN BOARD AT THE SITE AND CONFIRMED SYSTEM FUNCTIONALITY. ON 11/21/2013, BAYER HEALTHCARE DISTRIBUTED A FIELD SAFETY NOTICE RECALLING MAIN BOARDS WITH PART NUMBER 301641 THAT WERE INSTALLED IN SAME MEDRAD VERIS MR VITAL SIGNS MONITORS. THESE MAIN BOARDS ARE BEING RECALLED DUE TO THE POTENTIAL OF UNEXPECTED SHUTDOWN OF THE SYSTEM WHILE IN USE.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE VERIS MONITOR HAD SHUT DOWN DURING PT USE AFTER 10 MINUTES OF BEING POWERED ON. THE CUSTOMER CONFIRMED THAT THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114371 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MHX BAYER MEDICAL CARE, INC. 3014268W

    Patients

    Seq Age Sex Outcome Treatment
    1