BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3878213 · Received February 14, 2014

    Report

    Report Number
    2520313-2014-00010
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 24, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC
    Product Code
    MHX
    Removal / Correction Number
    Z-0810-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 HEALTH 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 MONITOR SHUT DOWN DURING A PATIENT EXAM. THE POWER WAS RESTORED BY PRESSING THE "ON" BUTTON. THE CUSTOMER CONFIRMED, VIA EMAIL CORRESPONDENCE, THAT THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97146 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MHX BAYER MEDICAL CARE, INC 3011993

    Patients

    Seq Age Sex Outcome Treatment
    1