SECHRIST INDUSTIES

Additional Manufacturer Narrative

CHAMBER WAS SERVICED BY A FIELD SERVICE TECHNICIAN, WHO CONFIRMED THE EMERGENCY VALVE DID NOT FUNCTION AS DESIGNED. THE EMERGENCY VALVE WAS REPLACED AND CHAMBER WAS VERIFIED TO FUNCTION AS EXPECTED. THE ROOT CAUSE IS ATTRIBUTED TO NORMAL WEAR AND TEAR OF A MECHANICAL COMPONENT. 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. CHAMBERS ARE MULTI-USE, SERVICEABLE ITEMS. AS SUCH, IT IS ANTICIPATED THAT THE UNITS MAY OCCASIONALLY REQUIRE REPAIR, AND AS PART OF STANDARD CARE THE CHAMBERS SHOULD BE INSPECTED PRIOR TO USE. IF DAMAGE OR FUNCTIONAL ISSUES ARE NOTED DURING THESE ROUTINE CHAMBER INSPECTIONS, THE UNIT SHOULD NOT BE PUT INTO USE WITH A PATIENT AND SHOULD BE REPORTED TO SECHRIST FOR SERVICING. 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

CUSTOMER REPORTED THE EMERGENCY VENT BUTTON IS NOT WORKING TO PERFORM EMERGENCY DECOMPRESSION TEST. CUSTOMER ALSO REPORTED THE TIMING IS OUT OF SPEC FOR COMPRESSION. NO PATIENT INCIDENT WAS REPORTED. ISSUE WAS DISCOVERED AT TIME OF ROUTINE TESTING.