BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 4152455 · Received October 6, 2014

    Report

    Report Number
    2520313-2014-00054
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER RADIOLOGY PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED VERIS MAIN PCB (PRINTED CIRCUIT BOARD) AND DETERMINED IT TO BE MALFUNCTIONING. BAYER RADIOLOGY SERVICE REPLACED THE PCB MAIN BOARD AT THE SITE AND CONFIRMED SYSTEM FUNCTIONALITY.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE VERIS MONITOR DROPPED SIGNAL DURING A SEDATION CASE. THE PATIENT EXAM WAS COMPLETED WITHOUT EVENT. 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
    622289 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI BAYER MEDICAL CARE, INC. 3011996W

    Patients

    Seq Age Sex Outcome Treatment
    1