SECHRIST INDUSTRIES INC.

Additional Manufacturer Narrative

UPON INSPECTION OF THE SAFETY BLOCK, TECH OBSERVED THE SAFETY PIN WOULD NOT FULLY RETRACT DURING USE, AND ALSO OBSERVED THE CHAMBER PRESSURE INDICATOR WOULD NOT ACTIVATE WHILE PRESSURIZED. REBUILT THE SAFETY INTERLOCK AND CHAMBER PRESSURE INDICATOR AND VERIFIED FULL FUNCTION. DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING AND FOUND NO NON-CONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE RISK IS MITIGATED TO THE LOWEST REASONABLE LEVEL THROUGH LABELING AND/OR INSTRUCTIONS IN THE USER'S MANUAL. SECHRIST RECOMMENDS COMPLETING DAILY, WEEKLY AND SEMI-ANNUAL PERFORMANCE VERIFICATION ON THE CHAMBER TO DETECT ANY ISSUES AND PRECLUDE THE DEVICE FROM USE. IN INSTANCES WHERE THE CHAMBER IS FOUND TO FUNCTION OUTSIDE OF SPECIFICATION, SECHRIST SHOULD BE IMMEDIATELY NOTIFIED FOR TECHNICAL ASSISTANCE. 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

CUSTOMER REPORTED THE RED CHAMBER PRESSURE INDICTOR IS NOT WORKING AND THAT ALSO THE DOOR LATCH IS GETTING STUCK AND NOT ALLOWING THE DOOR TO BE OPENED. ISSUE WAS DISCOVERED DURING CLINICAL CHECK AND THERE WAS NO PATIENT INVOLVEMENT.