SECHRIST INDUSTRIES INC.

Additional Manufacturer Narrative

EMERGENCY VENT BUTTON WAS DISASSEMBLED BY SI TECHNICIAN. UPON INSPECTION OF THE EMERGENCY VENT BUTTON, THREE WAY VALVE WAS STICKING AND NOT FULLY DEPRESSING WHEN PUSHED. PART WAS SWAPPED OUT BY TECHNICIAN AND EMERGENCY VENT BUTTON REASSEMBLED. CHAMBER WAS THEN TURNED ON AND COMPRESSED. EMERGENCY VENT BUTTON TESTED AND FOUND TO BE WORKING AS DESIGNED. CHAMBER WAS TAKEN TO 30 PSI AND CHAMBER FULLY DECOMPRESSED IN SPEC. COMPONENT WEAR DETERMINED TO BE THE CAUSE OF ISSUE. 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 FILE NO.: (B)(4).

Description of Event or Problem

AS REPORTED BY THE CUSTOMER, WHEN DOING WEEKLY CHECKS, NOTICED EMERGENCY VENT BUTTON WAS NOT WORKING PROPERLY. WHEN BUTTON PUSHED AND HELD DOWN THE DECOMPRESSION DID NOT BEGIN, INSTEAD HAD TO PUSH 4 OR 5 TIMES BEFORE DECOMPRESSION STARTED. NO PATIENT INVOLVEMENT OR INJURY REPORTED.