BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO RESEARCH 3500 MONITOR

    MDR report key: 436029 · Received January 1, 2003

    Report

    Report Number
    1051786-2002-00011
    Event Type
    Malfunction
    Date Received
    January 1, 2003
    Date of Event
    December 6, 2001
    Report Date
    December 31, 2002
    Manufacturer
    INVIVO RESEARCH INC.
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT MONITOR WAS SET UP TO PERFORM A SWAN-GANZ INSERTION PROCEDURE, AND THE PROCEDURE HAD BEGUN. DURING THE PROCEDURE THE MONITOR'S DISPLAY SUDDENLY SHOWED VERTICAL LINES ATOP ITS NORMAL DISPLAY, WHICH CAUSED VIEWING DIFFICULTIES. THE CLINICIAN REQUESTED ANOTHER MONITOR BE BROUGHT INTO THE PROCEDURE ROOM BY ANOTHER NURSE. THE PROCEDURE WAS DELAYED DUE TO THIS MALFUNCTION. THE REPORTER INDICATED THE PATIENT'S IV LINES WERE NOT IN AT THIS TIME DUE TO THE CENTRAL LINE BEING IN POSITION. THE REPORTER DESCRIBED THAT THE PATIENT'S DRUGS WERE DISCONTINUED AT THIS TIME (NO EXPLANATION GIVEN). THE CLINICAL STAFF DISCONTINUED THE PATIENT'S VASOPRESSOR MEDICATION TO MAINTAIN THE BLOOD PRESSURE. THE CENTRAL LINE WAS SET UP ON THE SECOND MONITOR, THE MONITOR WAS SET UP FOR THE INSERTION PROCEDURE, AND THE PROCEDURE WAS COMPLETED. SUBSEQUENT TO THIS PROCEDURE, THIS PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO RESEARCH 3500 MONITOR MULTI-PARAMETER PATIENT MONITOR MHY INVIVO RESEARCH INC. 3500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention