SECHRIST INDUSTRIES, INC.

Additional Manufacturer Narrative

THE SUSPECTED DEVICE WAS EVALUATED BY SECHRIST. THE RESTRICTOR THAT CONTROLS THE EMERGENCY DECOMPRESSION WAS REPLACED AND THE EMERGENCY DECOMPRESSION WAS CONFIRMED TO BE IN SPECIFICATION. THE RESTRICTOR'S FAILURE IS DUE TO NORMAL WEAR AND TEAR. MANUFACTURER REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

THE SUSPECTED DEVICE HAS NOT BEEN EVALUATED BY SECHRIST AT THIS TIME EVENTHOUGH WE HAVE REAHCED OUT TO USER TO SCHEDULE SERVICE CALL. THIS REPORT IS BASED ONLY ON THE INFORMATION PROVIDED BY USER WHEN REPORTING ISSUE TO SECHRIST. ONCE DEVICE IS EVALUATED AND ROOT CAUSE DETERMINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEEDED. 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).

Description of Event or Problem

CUSTOMER REPORTED THAT DURING PRE-CLINICAL CHECK THE CHAMBER IS FALLING OUTSIDE THE 120 SECOND TIME FRAME TO BE IN SPEC FOR THE EMERGENCY VENTING. NO PATIENT INVOLVEMENT OR PATIENT/USER INJURY REPORTED.