SECHRIST INDUSTRIES INC.

Additional Manufacturer Narrative

CUSTOMER IS REPORTING THAT THE CHAMBER IS EXTREMELY SLOW TO DECOMPRESS AT THE END OF THE TREATMENT AND HOLDING BACK RESIDUAL PRESSURE WHEN THE DOOR IS OPENED. PATIENT MADE COMPLAINT OF EAR PAIN WHEN DOOR WAS OPENED BY STAFF. THE CHAMBER WAS EVALUATED BY A TRAINED SECHRIST TECHNICIAN, IT WAS DETERMINED THAT THE CHAMBER WAS FUNCTIONING AS INTENDED AND WITHIN ITS SPECIFICATIONS. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THEREFORE, THE PATIENT INCIDENT WAS NOT A RESULT OF THE CHAMBER NOT FUNCTIONING PROPERLY. THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY AT THIS TIME. 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 ASESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO.: (B)(4).

Description of Event or Problem

CUSTOMER REPORTED, "THE CHAMBER IS EXTREMELY SLOW TO DECOMPRESS AT THE END OF TREATMENT AND HOLDING BACK RESIDUAL PRESSURE WHEN THE DOOR IS OPENED. PATIENT MADE COMPLAINT OF EAR PAIN WHEN THE DOOR WAS OPENED BY STAFF."