SECHRIST 3600E/ER MONOPLACE HYPERBARIC CHAMBER

Additional Manufacturer Narrative

THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORT OF A DEATH. NO DEVICE MALFUNCTION WAS REPORTED. THE DEVICE WAS NOT RETURNED TO SECHRIST. SECHRIST CERTIFIED TECHNICIAN VISITED THE FACILITY AND EVALUATED THE DEVICE. TECHNICIAN COMPLETED CHAMBER PERFORMANCE EVALUATION ON (B)(6) 2020, AFTER PATIENT INCIDENT. CHAMBER PERFORMED PER MANUFACTURER'S ANNUAL PREVENTIVE MAINTENANCE SPECIFICATIONS AND NO ERRORS WERE NOTED. THE INSTRUCTIONS FOR USE STATE "HYPERBARIC CHAMBERS ARE DESIGNED TO ADMINISTER OXYGEN AT 100% CONCENTRATION UP TO 3.0 ATMOSPHERES ABSOLUTE (ATA) OF PRESSURE." THE IFU ALSO STATES "CONTRAINDICATIONS MUST BE CAREFULLY WEIGHED BY THE PHYSICIAN WITH EACH PATIENT'S UNIQUE PREEXISTING CONDITIONS OR CONCURRENT THERAPIES." 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. (B)(4).

Description of Event or Problem

SECHRIST WAS NOTIFIED, BY A THIRD PARTY, ABOUT A SOCIAL MEDIA POST, OF A CHILD'S DEATH AT A HYPERBARIC THERAPY CLINIC, WHICH PROMPTED SECHRIST TO CONTACT THE FACILITY. SECHRIST WAS NOT INITIALLY NOTIFIED BY THE CLINIC WHEN THE INCIDENT TOOK PLACE. SECHRIST CONTACTED THE CUSTOMER WHO REPORTED THAT THEIR FACILITY TREATED AN (B)(6)-MONTH OLD CHILD WHO SUFFERED A NEAR DROWNING INCIDENT, WHICH OCCURRED IN (B)(6) 2020, AND LEFT THE CHILD IN A VEGETATIVE AND UNRESPONSIVE STATE. THE CHILD, ACCOMPANIED BY HIS FATHER INSIDE THE CHAMBER COMPLETED A 60 MINUTE HYPERBARIC TREATMENT. THIS WAS THE CHILD'S FIRST TREATMENT. AFTER THE TREATMENT, THE CHILD WAS ADMINISTERED CPR AND TAKEN TO THE EMERGENCY ROOM. THE HBO FACILITY WAS INFORMED THE CHILD PASSED OF CARDIORESPIRATORY ARREST.