BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN

    MDR report key: 2805402 · Received September 17, 2010

    Report

    Report Number
    3003900188-2010-00038
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 1, 2008
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT CASE IS ONE OUT OF 9 INCIDENT REPORTS IN CONNECTION WITH 7 LIV IGNITIONS. EVAL SUMMARY: ROOT CAUSE ANALYSIS SUMMARY - THE CAUSE OF IGNITION WITH HIGHEST PROBABILITY IS IGNITION OF HYDROCARBONS, LUBRICANT, AND/OR DEBRIS BY ADIABATIC COMPRESSION. POTENTIAL SOURCES OF HYDROCARBONS AND LUBRICANTS; LUBRICANT (FOMBLIN) MIGRATION (LUBRICANT FROM GCE MFG OF VALVE), LEACHING OF CONTAMINANTS (PHTHALATES) FROM O-RINGS IN VALVES (LUBRICANT IN SOLVENT) AND HYDROCARBON OIL, LEACHING OF CONTAMINANTS (PHTHALATES) FROM FILL CONNECTOR AT FILLING PLANT AT (B)(4). POTENTIAL SOURCES OF DEBRIS - DEBRIS FROM MFG PROCESS OF VALVE AT GCE, DEBRIS FROM FILLING PLANT AT (B)(4), DEBRIS FROM WEAR, VALVES IN USE. THE DESIGN (FILTER AND LOCATION OF COMPONENTS IN THE HIGH PRESSURE SIDE OF THE VALVE) OF THE GCE LIV VALVE 5 MICRON FILTER IS LIKELY TO CAUSE MORE SENSITIVITY TO ADIABATIC COMPRESSION HEATING THAN THE GCE OXYGEN DESIGN.

    Description of Event or Problem · 1

    THIS REPORT CONCERNS THE THIRD OUT OF THREE INDIVIDUALS INJURED IN THE PRESENT INCIDENT. OTHER CASES FOR THE SAME INCIDENT ARE: (B)(4). ON (B)(6) 2008, AN AMBULANCE IN (B)(6) WAS SENT TO AN EMERGENCY SITUATION, AS A PERSON HAD JUMPED OUT OF A WINDOW. THE PERSON WAS STILL ALIVE WHEN THE AMBULANCE ARRIVED AT THE SCENE AND ONE OF THE PARAMEDICS WANTED TO GIVE MEDICINAL OXYGEN TREATMENT (NORMAL PROCEDURE) TO THE PT. WHEN THE PARAMEDIC OPENED THE MAIN VALVE OF THE CONOXIA 2 LITER LIV CYLINDER, A LOUD BANG WAS HEARD AND AN OXYGEN FLAME CAME OUT OF THE CONOXIA CYLINDER. THE OXYGEN FLAME WENT THROUGH THE THREE LAYERS OF CLOTHS THAT THE PARAMEDIC WAS WEARING AND RESULTED IN BURN WOUNDS TO HIS BREAST (SIZE OF A HANDBALL) AND ARM. TWO POLICEMEN THAT WERE AT THE SCENE WERE ALSO SLIGHTLY INJURED (INJURIES UNK). THE PARAMEDIC THREW AWAY THE CYLINDER AFTER THE INCIDENT AND WAS TAKEN, TOGETHER WITH THE PT, TO THE NEAREST HOSPITAL (AROUND 5 MINUTES FROM THE SCENE). THE PARAMEDIC WAS TREATED IN THE HOSP FOR HIS BURN WOUNDS (MAINLY 1ST, BUT ALSO 2ND DEGREE) AND COULD RETURN TO HIS HOME LATER THAT NIGHT. ALL THE INJURED PERSONS COULD LEAVE THE HOSP AFTER NURSING AT THE FIRST AID DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN NONE ECX LINDE GAS NORTH AMERICA LLC 0710204 2551116

    Patients

    Seq Age Sex Outcome Treatment
    1