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AVIATION PRODUCT SAFETY NOTICE AND RECALL

www.oxyarmaviator.com/MHrecall

DATE: August 1, 2013

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FAILURES OF UNAPPROVED OXYARM IN ASSEMBLIES FOR AVIATION USE


APPLICABILITY This Safety Notice and Recall is directed to pilots, crew and passengers using OxyArms that have been re-branded and supplied in the Mountain High designed EZ Breathe Boom Cannula TM Kit.

REASON FOR NOTICE AND RECALL Testing has revealed failures of the OxyArms supplied in the EZ Breathe Cannula Kit. The Mountain High supplied aluminium ball mount component of the above labelled kit is incorrectly sized and/or manufactured. The oversized and coarsely machined ball is incompatible with the disposable homecare medical OxyArm and has caused repeated failures of the OxyArm cannulas. Mountain High claims the (OxyArm) tip provided in their EZ Breathe Kit has anti-microbial properties. It does not. In-flight failure of the OxyArm oxygen delivery device may cause pilot distraction at a critical phase of flight, pilot, crew and passenger hypoxia, serious personal injury and death. RECOMMENDED ACTION If you are in possession of a bare aluminium mounting ball supplied with a pressure sensitive adhesive pad, or your OxyArm tubing does not bear the requisite FAA Part 23.1447 tag it is recommended that you refrain from in-flight usage of an unapproved OxyArm. The genuine OxyArm Aviator kits are not affected by this recall. Consumer confusion may arise with EZ-Breathe kits containing parts labelled OxyArms. Genuine OxyArm Aviator assemblies bear the requisite FAA Part 23.1447 tags affixed with a Manufacture Date and Lot Code. The Mountain High supplied OxyArms have had the medical device labels removed and bear no MH label except on the retail packaging. The aviation distributor of genuine OxyArm Aviator Kits will replace counterfeit assemblies at no charge to the consumer. Contact MHrecall@oxyarmaviator.com for replacement.

BACKGROUND

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A reliable, proven and approved aviation life-support device is being counterfeited. A defective lookalike product is being passed off and sold to the public while still bearing the authentic devices molded-in trademark name. Mountain High Oxygen was a successful, trusted retailer of the OxyArm Aviator kit. As a result of their success with the product and our intention to expand our limited distribution, MH agreed to purchase intellectual property and global distribution rights to the patented OxyArm for aviation applications. Upon disclosure of confidential documents, Mountain High declined to complete the transaction, citing what they believed to be loopholes allowing competitors to create and market derivatives of the patented and trademarked OxyArm product line. Subsequently, Mountain High created and marketed their derivative EZ-Breathe Boom Cannula TM . The EZ Breathe kit uses an unmarked aluminium ball that is over-sized by a two hundreds of an inch but strains or breaks the close tolerance ball socket of the un-labelled medical OxyArm. Furthermore, our previous assessment of aluminium ball mounts revealed that machined aluminium surfaces do not provide the correct breakout force, friction profile nor reliable adhesion to a variety of headset substrates to keep the cannula safely seated in the nostrils during cockpit use. The coarse machining marks on the Mountain High product can damage the edges of the plastic OxyArm. Latent weakening of the adhesive pad bond is also a concern if exposed to the cabin temperatures of aircraft parked in the sun. To obtain medical OxyArms, Mountain High represented themselves as a medical supply company and procured the devices under that pretense. Medical OxyArms are registered as a Class 1 Medical Device and are subject to dispensing controls under a physicians prescription. The medical OxyArm devices are considered single use disposable devices in hospital settings and are not designed for long term cockpit use. Furthermore, Mountain High states in their literature that the cannula tip is anti-microbial. It is not. The OxyArm Aviator tips are treated with FDA approved, DIN registered Aegis GermGuard, the single use OxyArms are not. We believe that Mountain High Oxygen and its affiliated companies have been distributing this lookalike OxyArm product through their website, Aircraft Spruce and Specialty, and The Pilot Shop since early 2013. We are concerned for the safety of pilots and their passengers as well as product liability and our reputation. Genuine OxyArm Aviator boom cannulas are designed, tested and manufactured in an ISO certified, controlled clean room facility in Ontario, Canada. Aviation specific kits are manufactured and processed as a complete assembly with materials and tolerances that evolved specifically in the aviation application. Initial breakout force, friction and closed cockpit heat considerations resulted in an evolved complete assembly since their introduction in 2007, and the Version 2.0 released in mid-2011. With over 5,000 genuine kits delivered, there have only been 31 reported failures of the original mounting ball. 23 of those failures occurred in the first year. The overall failure rate of the genuine OxyArm Aviator is 0.0062. The failure rate since 2009 is 0.002 or 2/10ths of one percent. The genuine OxyArm Aviator is a reliable, proven product. There have been no reported failures of any V. 2.0 OxyArm Aviator. Original OxyArm Aviator customers can upgrade to Version 2.0 at a reduced price at any time.

If you have been sold, or know of someone that is using, this unapproved OxyArm derived kit, please visit www.oxyarmaviator.com/MHrecall or contact MHrecall@oxyarmaviator.com to arrange for a free replacement OxyArm Aviator 2.0 Kit.