SECHRIST INDUSTRIES INC.

Additional Manufacturer Narrative

A GETINGE FIELD SERVICE TECHNICIAN WAS SENT FOR INVESTIGATION AND REPAIR ON 2025-09-29. THE SECHRIST GAS MIXER WAS REPLACED. THE AIR-OXYGEN MIXER MUST BE REPLACED WITH A NEW ONE. THE AIR-OXYGEN MIXER IS UNSUITABLE FOR CLINICAL USE. THE REPORTED FAILURE DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. SINCE NO SYSTEMIC ISSUE WAS DETERMINED NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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. THE IFU STATES, "TO ENSURE PROPER FUNCTION AND ACCURACY, THE SECHRIST AIR/OXYGEN GAS MIXERS MUST BE THOROUGHLY OVERHAULED EVERY TWO (2) YEARS. TO MAINTAIN THE PRODUCT WARRANTY, THE OVERHAUL MUST BE PERFORMED BY SECHRIST INDUSTRIES OR BY SECHRIST AUTHORIZED PERSONNEL." 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

IT WAS REPORTED THAT BLOOD HAS ENTERED THE GAS MIXER. NO HARM TO ANY PERSON WAS REPORTED.