AVIATION PRODUCT SAFETY NOTICE AND RECALL

www.oxyarmaviator.com/MHrecall

DATE: August 1, 2013

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FAILURE OF UNAPPROVED OXYARM IN MH KITS 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 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 has caused repeated failures of the singleuse medical 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. Genuine OxyArm Aviator assemblies bear the requisite FAA Part 23.1447 tags affixed with the Manufacturer Name, Date, Lot Code. The Mountain High supplied OxyArms carry the molded-in OxyArm trademark but have had the medical device labels removed. The MH EZ-Breathe system components bear no label of MH origin. The EZ Breathe Instruction Manual is an edited version of the OxyArm Aviator Instruction Manual. The aviation distributor of genuine OxyArm Aviator Kits will replace counterfeit systems 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 system is being counterfeited. A 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 investigated purchasing 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 and may strain or break the close tolerance ball socket of the un-labelled medical OxyArm. Furthermore, our previous assessment of aluminium ball mounts revealed that turned metal 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 the plastic OxyArm. Latent weakening of the adhesive pad bond is a concern if exposed to the cabin temperatures of aircraft parked in sun. To obtain medical OxyArms, Mountain High mis-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 incorporate an FDA approved, DIN registered Aegis GermGuard, the single use OxyArms do not. We believe that Mountain High Oxygen and its affiliated companies have been distributing this lookalike OxyArm system through their own 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 systems 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 six years ago, and the Version 2.0 released in mid-2011. With over 5,000 genuine kits delivered, 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 systems. 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.