BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3800540 · Received February 11, 2014

    Report

    Report Number
    2520313-2014-00008
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 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 MAINBOARD AT THE SITE AND CONFIRMED SYSTEM FUNCTIONALITY. ON (B)(6) 2013, (B)(4) 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

    A BAYER R & I REPRESENTATIVE REPORTED THE FOLLOWING: THE SYSTEM WOULD RANDOMLY TURN OFF WHILE IN USE. THE CUSTOMER CONFIRMED, VIA TELEPHONE CONVERSATION, THAT THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89034 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MHX BAYER MEDICAL CARE, INC. 3011994W

    Patients

    Seq Age Sex Outcome Treatment
    1