BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3642741 · Received December 20, 2013

    Report

    Report Number
    2520313-2013-00074
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    December 4, 2013
    Report Date
    December 4, 2013
    Manufacturer
    MEDRAD
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 21, 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

    SUBSEQUENT TO RECEIPT OF THE FIELD SAFETY NOTICE, A BAYER R AND I REPRESENTATIVE REPORTED THE FOLLOWING INFORMATION VIA EMAIL CORRESPONDENCE: THE SYSTEM WENT DOWN AFTER 20 MINUTES OF USAGE. THERE WAS NO INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670006 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI MEDRAD 3011994W

    Patients

    Seq Age Sex Outcome Treatment
    1