BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3770087 · Received January 28, 2014

    Report

    Report Number
    2520313-2014-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 10, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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 BOARD 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 SYSTEM HAD STOPPED MULTIPLE TIMES DURING A PATIENT EXAM. THE POWER WAS RESTORED EACH TIME WHEN THE "ON" BUTTON WAS DEPRESSED AND THE EXAM WAS ABLE TO BE COMPLETED. THE CUSTOMER CONFIRMED THAT THERE WAS NO INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61440 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MHX BAYER MEDICAL CARE, INC. 3011994

    Patients

    Seq Age Sex Outcome Treatment
    1