SECHRIST INDUSTRIES INC.

Description of Event or Problem

CUSTOMER REPORTING TO SECHRIST, "THAT AFTER THEIR CHAMBER WAS SERVICED BY A THIRD-PARTY, THEIR PATIENTS ARE EXPERIENCING BAROTRAUMA DURING TREATMENTS. THIS HAS HAPPENED ON MULTIPLE PATIENTS."

Additional Manufacturer Narrative

CUSTOMER REPORTED THAT AFTER THEIR CHAMBER WAS SERVICED BY A THIRD-PARTY THAT MULTIPLE PATIENTS HAVE EXPERIENCED BARAOTRAUMA DURING TREATMENT. THE CHAMBER HAS BEEN EVALUATED BY A SECHRIST TRAINED TECHNICIAN AND IT WAS VERIFIED THAT THE CHAMBER WAS FUNCTIONING AS INTENDED. 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 RESPONSE 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).