BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGM ANESTHESIA GAS ANALYZER

    MDR report key: 631888 · Received August 2, 2005

    Report

    Report Number
    631888
    Event Type
    Malfunction
    Date Received
    August 2, 2005
    Date of Event
    July 8, 2005
    Report Date
    August 2, 2005
    Manufacturer
    DATEX OHMEDA
    Product Code
    CCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ENCLOSED IS A COPY OF THE 5250 RESPIRATORY GAS MONITOR OPERATION AND MAINTENANCE MANUAL, PART #6050-004-020; 5250 RESPIRATORY GAS MONITOR SERVICE MANUAL, PART #6050-0004-022; AND PERFORMANCE TESTING RESULTS, DATED JANUARY 9, 1992, FOR THE AXC-200 BENCH. THE SAMPLE (BENCH) WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE BENCH WAS INSTALLED IN A CALIBRATION CHAMBER FOR TESTING. THE MEASUREMENT RESULTS WERE WITHIN MANUFACTURER'S SPECIFICATIONS, HOWEVER, THE MEASURIGN CARD ALARMED "SAMPLING SYSTEM ERROR" DUE TO THE WEAK SIGNAL FROM THE BENCH. SIGNAL LEVELS WERE SUBSEQUENTLY CHECKED, AND IT WAS FOUND THAT THE SIGNAL DECREASED TO APPROX. 1/3 OF THE ORIGINAL. THE SIGNAL DECREASED TO APPROX. 1/3 OF THE ORIGINAL. THE SIGNAL FROM THE MEASURING SIDE AND REFERENCE SIDE WERE EQUAL, WHICH INDICATES THAT THERE IS NO DIRT INSIDE THE BENCH. THE INFRARED SOURCE RESISTANCE WAS THEN CHECKED AND FOUND TO BE WITHIN MANUFACTURER'S SPECIFICATION. THE UNIT WAS SUBSEQUENTLY TESTED WITH A NEW IR SOURCE, PROVIDING THE SAME RESULTS (DECREASE IN SIGNAL). THE BENCH WAS OPENED AND VISUALLY INSPECTED, AND NO ANOMALIES WERE NOTED. THE UNIT WAS TESTED WITH ANOTHER PREAMPLIFIER BOARD, AND THE SIGNAL LEVELS WERE WITHIN SPECIFICATION. IT APPEARS THAT A WEAK IR DETECTOR CAUSED THE SIGNAL DROP FROM THE BENCH. AMPLIFICATION OF THE PREAMPLIFIER CARD WAS INCREASED, BRINGING THE SIGNAL LEVEL TO WITHIN SPECIFICATION. THE EXACT ROOT CAUSE OF THE IR DETECTOR COMPONENT FAILURE COULD NOT BE DETERMINED. GE HEALTHCARE'S EVALUATION OF THE REPORTED COMPLAINT DETERMINED IT WAS NOT A REPORTABLE EVENT THAT REQUIRED A MANDATORY REPORT BY THE MANFACTURER. THE UNIT OPERATED AS DESIGNED, ALARMING `GAS ANALYZER INOPERATIVE' WHEN THE UNIT DETECTED A PROBLEM. THERE WAS NO REPORTED PATIENT INJURY (AS STATED IN THE USER REPORT). MANUFACTURING OF THE 5250 RESPIRATORY GAS MONITOR ENDED DECEMBER 2001.

    Description of Event or Problem · 1

    AN ANESTHESIA GAS MONITOR BEING USED IN THE OPERATING ROOM FAILED SHORTLY AFTER THE PATIENT'S INDUCTION. IT DISPLAYED THE MESSAGE, GAS ANALYZER INOPERATIVE. THE MONITOR WAS THEN SWITCHED OUT FOR A SAME MODEL REPLACEMENT. THE OPERATION CONTINUED WITHOUT FURTHER INCIDENTS REGARDING THE MONITOR. IT WAS TAKEN TO THE BIOMEDICAL ENGINEERING DEPARTMENT FOR TROUBLESHOOTING. DURING THE EXAM, ANOTHER INDICATOR DISPLAYED WAS A??AGENT DETECTEDA?? EVEN THOUGH THERE WAS NO AGENT BEING INTRODUCED. IT IS BEING SENT OUT TO THE MANUFACTURER FOR REPAIR. THE PATIENT WAS NOT INJURED BY THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RGM ANESTHESIA GAS ANALYZER ANESTHETIC GAS MONITOR CCL DATEX OHMEDA RGM *

    Patients

    Seq Age Sex Outcome Treatment
    1 *