SECHRIST INDUSTRIES, INC.

Description of Event or Problem

CUSTOMER REPORTING THAT DURING TREATMENT A PATIENT HAS AN EAR ISSUE WHILE ASCENDING TO TREATMENT PRESSURE. CUSTOMER NOTICED THAT THE CHAMBER TRAVELED MUCH FASTER AROUND FOUR (4) MINUTES INSTEAD OF NORMAL WHICH IS SEVEN (7) MINUTES.

Additional Manufacturer Narrative

THIS REPORT IS BASED ON INFORMATION THAT CURRENTLY HAVE. THE DEVICE HAS NOT BEEN EVALUATED BY SECHRIST AT THIS TIME AS THE CUSTOMER HAS YET TO RESPOND TO SERVICING REQUESTS BY SECHRIST. SECHRIST IS REPORTING BASED ONLY ON THE REPORTED PATIENT INJURY (EAR PAIN) EVEN THOUGH YET TO CONFIRM IF A RESULT OF OUR DEVICE AT THIS TIME. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE.THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE NO. (B)(4).