BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3810818 · Received March 21, 2014

    Report

    Report Number
    2520313-2014-00019
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 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, THE SITE REPORTED THE FOLLOWING: THE VERIS MONITOR SHUT DOWN DURING USE ON A NON-SEDATED ICU PATIENT. THE POWER WAS NOT ABLE TO BE RECYCLED BY PRESSING THE "ON" BUTTON. 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
    169287 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MHX BAYER MEDICAL CARE, INC. 3011996W

    Patients

    Seq Age Sex Outcome Treatment
    1