BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3834775 · Received March 20, 2014

    Report

    Report Number
    2520313-2014-00016
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    BAYER MEDICAL CARE INC
    Product Code
    MHX
    Removal / Correction Number
    Z-0810-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R& I SERVICE REPLACED THE SYSTEM MAIN BOARD AND CONFIRMED SYSTEM FUNCTIONALITY. ON (B)(6) 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

    THE SITE REPORTED THE FOLLOWING: THE VERIS MONITOR HAD SHUT DOWN DURING PATIENT USE. THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165336 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PYSIOLOGICAL PATIENT MHX BAYER MEDICAL CARE INC 3011992

    Patients

    Seq Age Sex Outcome Treatment
    1