Warning issued by RA Medical Services Ltd re Medical oxygen air cyclinders

In January 2013 the MHRA issued a Medical Device Alert MDA/2013/002 with regard to medical oxygen and medical air cylinders filled to These are being supplied into the UK, under European Law, by SOL Spa/BTG Gases.  An incident recently occurred at a Trust where it appears one of these 200 bar oxygen pin index cylinders was connected to a Quantiflex Analogue MDM mounted on a Mobile 4 Cylinder Stand.  This unit had been serviced by one of our engineers in January 2013 and was in O.E.M. working order at that time.  In early February 2013 we received a call from the Trust stating the equipment was malfunctioning.  Our engineer attended and service exchanged the whole unit, returning the faulty one to our Service Centre for evaluation.  On examination, the calibration was well outside manufacturing tolerance and displaying areas of oxygen leakage.  This is unknown in a unit that has been regularly maintained and only less than a month into the service warranty period.  We were, of course, unable to test the unit with a 200 bar cylinder in place.


 Currently, Inhalation Sedation equipment is not designed to be used with cylinders filled to more than 137 bar and indeed, current regulators fitted to mobile 4 cylinder stands are not designed to withstand inlet pressures of more than 138 bar.  This also applies to pipework and gauges.  R A Heads are designed to be used with a nominal inlet pressure of 4 bar and use of 200 bar oxygen cylinders is likely to cause significant damage.  Therefore we are issuing a warning against us of these SOL Spa/BTG Gases cylinders with Inhalation Sedation equipment as it will immediately negate any equipment warranty in place and has the potential to be a causative factor in a more serious occurrence involving physical damage to dental personnel.


 Both the MHRA and the Medical Gas Association are aware of the situation and are monitoring the use of these cylinders in the dental environment.  All dental staff should be made aware that these new 200 bar cylinders should not be used in conjunction with Inhalation Sedation equipment at any time.

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