BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2805492 · Received September 22, 2008

    Report

    Report Number
    3003900188-2009-00032
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Product Code
    ECX
    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. EVALUATION 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 MANUFACTURING 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 LINDE POTENTIAL SOURCES OF DEBRIS. DEBRIS FROM MANUFACTURING PROCESS OF VALVE AT GCE. DEBRIS FROM FILLING PLANT AT LINDE. 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

    INFORMATION WAS RECEIVED ON (B)(6) 2009, THAT A CLIENT FIRE BRIGADE IN (B)(6) 2009 HAD OBSERVED AN IGNITION OF A LIV OXYGEN. AS (B)(6) CREW PUT ON THE CYLINDER FOR SERVICE (FIRST OPENING) SPARKS OCCURRED AROUND THE BOTTOM VALVE OPENING. THE VALVE WAS CLOSED, BUT SPARKS CONTINUED OUT OF THE BOTTOM OF THE VALVE (ASSEMBLY SHROUD AND OUTLET CONNECTION). THERE WERE NO INJURIES AND THERE IS NO DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCE COMBILITE I VIPRS, 5 MICRO FILTER, LIV FOR OXYGEN NONE ECX LINDE GAS NORTH AMERICA LLC 070137 2980643

    Patients

    Seq Age Sex Outcome Treatment
    1