SECHRIST INDUSTRIES, INC.

Additional Manufacturer Narrative

CUSTOMER REPORTED THAT DURING TREATMENT IN A SECHRIST MONOPLACE HYPERBARIC CHAMBER THAT THE PATIENT HAD A SEIZURE. THE CUSTOMER WANTED THE CHAMBER EVALUATED TO SEE IF FUNCTIONING AS INTENDED OR NOT. AFTER THE CHAMBER WAS EVALUATED BY TRAINED SECHRIST TECHNICAIN, IT WAS DETERMINED THAT THE CHAMBER WAS FUNCTIONING AS INTENDED AND WITHIN ITS SPECIFICATIONS. THERERFORE, THE PATIENT INCIDENT WAS NOT A RESULT OF THE CHAMBER NOT FUNCTIONING PROPERLY. THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY AT THIS TIME. 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 ASESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO.: (B)(4).

Description of Event or Problem

CUSTOMER REPORTED TO SECHRIST THAT DURING TREATMENT IN SECHRIST MONPLACE HYPERBARIC CHAMBER, THE PATIENT EXPERIENCED A SEIZURE.