SECHRIST INDUSTRIES INC.

Additional Manufacturer Narrative

DEVICE WAS EVALUATED BY SECHRIST AND DETERMINED THAT THE REED WAS DEFECTIVE WHICH LED TO THE ALARM NOT SOUNDING PROPERLY. THE REED WAS REPLACED AND THE UNIT WAS TESTED AND FOUND TO BE ALARMING PROPERLY NOW. THE IFU STATES, PRIOR TO EACH CLINICAL USE, THE USER SHALL PERFORM BYPASS ALARM SYSTEM TEST, VERIFY ACCURACY OF O2 AND INSPECT THE REVERSE GAS FLOW. 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 THE MIXER WON'T ALARM AND HAS A HISSING SOUND COMING FROM IT. NO PATIENT INVOLVEMENT OR INJURY REPORTED.