BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISELECT II

    MDR report key: 19227590 · Received May 2, 2024

    Report

    Report Number
    3003207908-2022-00002
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    June 6, 2022
    Report Date
    April 30, 2024
    Manufacturer
    GCE, S.R.O.,
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IGNITION WAS CAUSED BY THE BURST OF UNSPECIFIED IMPURITIES IN THE SPACE BETWEEN THE OUTPUT FROM THE CYLINDER VALVE AND THE INLET STEM OF THE MOUNTED HIGH PRESSURE REGULATOR. - THE IGNITION COULD BE CAUSED BY ONE OF THE FOLLOWING PHENOMENA: - ADIABATIC COMPRESSION WITHIN THE ASSEMBLY UNIT/QUICK OPENING OF THE CYLINDER VALVE - THERMAL ENERGY GENERATED BY THE HIGH VELOCITY OF OXYGEN FLOW THROUGH AN UNSPECIFIED LEAKAGE.

    Description of Event or Problem · 0

    ORIGIN DESCRIPTION OF THE EVENT PROVIDED BY THE PRESENTED STAFF MEMBER AT (B)(6): ON (B)(6) 2022, I STARTED THE NIGHT SHIFT ON RV D134. AFTER I TOOKOVER THE VEHICLE FROM (B)(6)., WHO WAS ON THE DAY SHIFT, I WENT OVER TO CHECK THE EQUIPMENT AND CONDITION OF THE VEHICLE. WHILE CHECKING THE OXYGEN LEVEL IN THE TWO-LITER CYLINDER, LOCATED IN THE BACKPACK ALONG WITH THE VENTILATOR, I NEEDED TO FIND OUT WHAT THE ACTUAL PRESSURE IN THE CYLINDER WAS. ON THE PRESSURE REDUCING VALVE GAUGE, THE PRESSURE WAS AT 0. I CHECKED THE TIGHTENING OF THE PRESSURE REDUCING VALVE NUT AND AFTER FINDING IT TIGHTENED SUFFICIENTLY, I SLOWLY OPENED THE OXYGEN CYLINDER WITH THE MAIN VALVE TRIGGER. BY THE TIME THE OXYGEN HAD FLOW ONLY TO THE PRESSURE REDUCING VALVE, WHICH WAS SET AT 0 L/MIN, OXYGEN BEGAN TO LEAK OUT. THEN SMOKE APPEARED AROUND THE PRESSURE REDUCING VALVE NUT. AS MY HAND WAS STILL ON THE MAIN VALVE TRIGGER, I IMMEDIATELY CLOSED THE BOTTLE. THE OXYGEN LEAK COULD LAST ABOUT A SECOND, AND THERE WAS NO FURTHER AUDIBLE LEAKAGE. THE PRESSURE-REDUCING VALVE NUT WAS FUMING, AND IT WAS VERY HOT. THIS EVENT HAPPENED APPROXIMATELY AT 18.40. IN THE AMBULANCE NEXT DOOR, (B)(6) (HEAD NURSE) WAS JUST PERFORMING MAINTENANCE BEFORE THE END OF THE DAY SHIFT, I CALLED HIM TO THE PLACE OF INCIDENT IMMEDIATELY. ON HIS ARRIVAL, THERE WAS A SMELL OF SMOKE BUT ON A VISUAL INSPECTION THERE WAS NO EVIDENCE OF OXYGEN LEAKAGE. BY THE TIME (B)(6) CONTACTED THE FIRE DEPARTMENT, I HAD DISCONNECTED THE HIGH-PRESSURE VALVE'S QUICK COUPLER FROM THE FAN AND REMOVED THE BOTTLE AND HIGH-PRESSURE VALVE FROM THE BACKPACK. UNTIL THE FIREFIGHTERS ARRIVED ON THE PLACE OF INCIDENT, WE LEFT THE BOTTLE ON THE GROUND AND WATCHED TO SEE IF THE CONDITION WOULD CHANGE. AFTER THE ARRIVAL OF THE (B)(6), WE HANDED OVER THE OXYGEN CYLINDER. THE FIREFIGHTERS CARRIED OUT AN INSPECTION WITH A THERMAL IMAGING CAMERA AND THEN, AFTER A TELEPHONE CONSULTATION, DISCONNECTING THE PRESSURE REDUCING VALVE. IT WAS FOUND THAT THERE WAS A FIRE IN THE AREA OF THE TRANSITION OF THE CYLINDER VALVE TO THE HIGHPRESSURE VALVE. THE SEALING OF THE HIGH-PRESSURE VALVE WAS BURNED AND DISINTEGRATED. A POLICE OFFICERS ARRIVED AT THE PLACE OF INCIDENT WE PASS ON THE OXYGEN CYLINDER AND THE HIGH PRESSURE VALVE TO THE FIRE BRIGADE, WHO TOOK EVERYTHING AWAY FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811592 MEDISELECT II MEDISELECT II CAN GCE, S.R.O., 0720115 8282984

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other