BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNITUDE

    MDR report key: 598120 · Received April 27, 2005

    Report

    Report Number
    598120
    Event Type
    Malfunction
    Date Received
    April 27, 2005
    Date of Event
    March 22, 2005
    Report Date
    April 19, 2005
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN MRI, FACILITY STAFF WERE UNABLE TO GET THE END TIDAL CARBON DIOXIDE (ETC02) MONITOR TO WORK ON A REMOTE UNIT (3150 INVIVO). STAFF WAS ABLE TO MONITOR THE VENTED PATIENT WITH OXYGEN SATURATION MONITORING AND OBSERVING CHEST RISE AND FALL. NO ADVERSE OUTCOME TO PATIENT. INHOUSE BIOMEDICAL ENGINEERING TECHNICIAN WAS CONTACTED IMMEDIATELY. THE UNIT WAS REMOVED AND BROUGHT TO DEPT. FOR EVALUATION. TESTING REVEALED THAT THE UNIT WORKED JUST FINE AND SO IT WAS RETURNED TO THE MRI DEPARTMENT. STAFF WERE PROCEEDING WITH ANOTHER CASE A DAY OR TWO LATER AND THE SAME THING HAPPENED (ETC02 NON-FUNCTIONING). BIOMED CAME TO THE DEPARTMENT AND LOOKED AT THE MONITOR DURING THE CASE, BUT COULD NOT GET IT TO WORK. NEXT, THE TECH CONTACTED INVIVO AND THE CONCLUSION WAS THAT ONE PART OF THE REMOTE UNIT WAS A LOANER AND THIS LOANER UNIT WAS NOT PRE-PROGRAMMED FOR ETC02. BIOMED PROGRAMMED IT AND IT WORKS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNITUDE MONITOR, PHYSIOLOGICAL, MRI COMPATIBLE MWI INVIVO RESEARCH, INC. 3150MR! *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR