SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3600H/HR

Additional Manufacturer Narrative

UPON INSPECTION OF CHAMBER, SECHRIST TRAINED TECHNICIAN NOTICED DAMAGE TO THE DOOR GASKET, DAMAGED NOTED TO TOP END CAP OF CAM SHAFT AND TRACK THAT TOP CAP SITS IN, SCORE MARKING NOTED ON LOWER LOCK ARM COVER AS WELL, AND BEND NOTED IN HANDLE KNOB. SERVICE REPAIR HAS NOT BEEN COMPLETED AS OF YET BUT THE USER FACILITY HAS TAKEN THE CHAMBER OUT OF SERVICE UNTIL REPAIRS COMPLETED. A DHR REVIEW FOUND NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. 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 PREVENTIVE 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

DURING TREATMENT AT 2.5 ATA HEARD A LOUD POPPING SOUND, AND STAFF NOTICED CHAMBER PRESSURE DECREASED IMMEDIATELY TO 0 PSI. IT TOOK STAFF APPROXIMATELY 5 MINUTES TO OPEN DOOR, IN WHICH THE DOOR GASKET AND PART OF THE GROUND CORD WAS EXTRUDED BETWEEN THE DOOR AND DOOR RING. NO PATIENT OR USER INJURY WAS REPORTED.

Additional Manufacturer Narrative

11/08/2022 - SERVICE OF THE CHAMBER HAS BEEN COMPLETED BY SECHRIST TECHNICIAN. THE ROOT CAUSE OF THE EVENT IS DUE TO A DAMAGED DOOR GASKET THAT WAS NOT DETECTED BY THE USER. THE OTHER DAMAGE TO CHAMBER WAS CAUSED BY THE SIDE EFFECTS OF THE DAMAGED DOOR GASKET. CHAMBER HAS BEEN SERVICED AND VERIFIED TO BE IN PROPER WORKING ORDER TO BE PUT BACK INTO SERVICE BY THE USER FACILITY. MANUFACTURER REFERENCE FILE NO. (B)(4).

Description of Event or Problem

SUPPLEMENTAL REPORT REQUIRED FOR DEVICE EVALUATION RESULTS.