BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3612441 · Received December 6, 2013

    Report

    Report Number
    2520313-2013-00055
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDRAD
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R & I PRODUCT ANALYSIS RECEIVED AND EXAMINED THE SUSPECT MAIN PCB (PRINTED CIRCUIT BOARD) AND DETERMINED IT TO BE MALFUNCTIONING. BAYER R & I (SERVICE REPLACED THE PDB MAIN BOARD AT THE SITE AND CONFIRMED SYSTEM FUNCTIONALITY. ON NOVEMBER 21,2 013, 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

    THE SITE REPORTED THE FOLLOWING: DURING TWO SEDATION CASES, THE SCREEN WOULD GO BLANK, BUT THEN WOULD TURN BACK ON WHEN THE POWER BUTTON IS PRESSED. THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634878 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI MEDRAD 3014268

    Patients

    Seq Age Sex Outcome Treatment
    1