SECHRIST INDUSTRIES INC.

Additional Manufacturer Narrative

CUSTOMER REPORTED THAT ON A FEW OCCASIONS THAT THE CHAMBER PRESSURE WAS PULSING/WHOOSHING UPON COMPRESSION ABOUT 2.4 ATA, WITH PATIENT COMPLAINTS OF EAR PAIN DURING TREATMENT. THE CHAMBER HAS BEEN EVALUATED BY A SECHRIST TRAINED TECHNICIAN AND IT WAS VERIFIED THAT THE CHAMBER WAS FUNCTIONING AS INTENDED. THE REPORTED ISSUE COULD NOT BE REPLICATED OR CONFIRMED. NO ISSUES WERE DISCOVERED THAT WOULD CONFIRM THAT THE CHAMBER WAS THE CAUSE OF THE PATIENTS EXPERIENCING BAROTRAUMA. BAROTRAUMA IS A MINOR INCONVENIENCE TO PATIENT THAT WILL RESOLVE ON ITS OWN OR WITH MINIMAL MEDICAL INTERVENTION. THIS REPORT IS BEING SUBMITTED SOLEY IN RESPONE TO A PATIENT INJURY BEING REPORTED AS THERE WAS NO ISSUES DISCOVERED UPON MANUFACTURER EVALUATION OF THE SUSPECTED DEVICE. 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).

Description of Event or Problem

CUSTOMER REPORTED TO SECHRIST THAT NOTED ON A FEW OCCASIONS THE CHAMBER PRESSURE PULSING/WHOOSHING UPON COMPRESSION AT 2.4 ATA, WITH PATIENT COMPLAINTS OF EAR PAIN.