SECHRIST INDUSTRIES INC.

Additional Manufacturer Narrative

CUSTOMER REPORTED THAT THE CHAMBER DOOR LOCKING PIN IN NOT ENGAGING UNTIL 4.2 PSIG AND WILL RETRACT AT 7.0 PSIG ON DECOMPRESSION. NO PATIENT OR USER INJURY REPORTED. THE CHAMBER HAS BEEN EVALUATED BY A SECHRIST TRAINED TECHNICIAN AND IT WAS DISCOVERED THAT ONE OF THE SAFETY BLOCK NIPPLES WAS BENT. THE BENT NIPPLE RESULTED IN RESTRICTION OF THE GAS FLOW WHICH ACCOUNTED FOR THE DELAY IN THE PIN EXTENDING AND THE PREMATURE RETRACTION OF PIN. THEREFORE, THE ISSUE WAS CONFIRMED. THE SAFETY BLOCK NIOPPLE WAS BENT BY THE GURNEY HITTNG THE SAFETY BLOCK WHEN PULLING THE GURNEY AWAY FROM THE CHAMBER. THE USER WAS INFORMED AND INSTRUCTED ON HOW TO PROPERLY PULL GURNEY WAY FROM CHAMBER WITHOUT HITTING SAFETY BLOCK. 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 TO SECHRIST THAT THE CHAMBER DOOR LOCKING PIN IS NOT ENGAGING UNTIL 4.2 PSIG AND WILL RETRACT AT 7.0 PSIG ON DECOMPRESSION. NO PATIENT OR USER INJURY REPORTED.