SECHRIST HYPERBARIC OXYGEN CHAMBER MODEL 2500B

Description of Event or Problem

ON DECEMBER 18, 2024, SECHRIST BECAME AWARE OF A SERIOUS INCIDENT RELATED TO MISUSE OF SECHRIST HYPERBARIC CHAMBERS. IT WAS REPORTED BY THE DIRECTOR OF CMC CERTIFICANDO, WHO ACTS ON BEHALF OF THE BRAZILIAN NAVY, THAT TWO (2) FACILITIES IN BRAZIL ARE OPERATING WITH HYPERBARIC CHAMBERS THAT ARE NOT QUALIFIED TO BE IN OPERATION AND IN A PRECARIOUS OPERATIONAL CONDITION. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. ON DECEMBER 18, 2024, SECHRIST BECAME AWARE OF A SERIOUS INCIDENT RELATED TO MISUSE OF SECHRIST HYPERBARIC CHAMBERS. IT WAS REPORTED BY THE DIRECTOR OF CMC CERTIFICADORA, WHO ACTS ON BEHALF OF THE BRAZILIAN NAVY, THAT TWO (2) FACILITIES IN BRAZIL ARE OPERATING WITH HYPERBARIC CHAMBERS THAT ARE NOT QUALIFIED TO BE IN OPERATION AND IN A PRECARIOUS OPERATIONAL CONDITION. SECHRIST INITIAL INVESTIGATION HAS IDENTIFIED THE CHAMBERS BEING UTILIZED AS MODEL 2500B SN (B)(6) MANUFACTURED 1998 (26 YRS OLD). THIS CHAMBER HAS OUT LIVED THEIR USEFUL LIFE. IT WAS ALSO REPORTED THAT THESE CHAMBERS ARE BEING USED TO TREAT PATIENTS, AND IN A RECENT INCIDENT CLINIC STAFF WERE UNABLE TO OPEN ONE OF THE DOORS OF A CHAMBER TO REMOVE A PATIENT INSIDE. THE PATIENT HAD TO REMAIN INSIDE THE CHAMBER FOR APPROXIMATELY 50 MINUTES BEFORE EVENTUALLY BEING REMOVED SAFELY AND WITHOUT SERIOUS IMPACT OR INJURY REPORTED. SECHRIST INSTRUCTIONS FOR USE STATE, "TO ENSURE THAT YOUR EQUIPMENT IS IN OPTIMAL CONDITION FOR THE LIFE OF THE CHAMBER, SECHRIST RECOMMENDS A 10-YEAR TUNE-UP FOR ALL SECHRIST HYPERBARIC CHAMBER MODELS WHEN THEY REACH EITHER 10 YEARS FROM THE DATE OF MANUFACTURE OR HAVE REACHED 10,000 CYCLES, WHICHEVER COMES FIRST." THE ACRYLIC CYLINDER MINIMUM DESIGN LIFE EXPECTANCY PER THE ASME, PVHO-1 STANDARD IS 10 YEARS, 10,000 CYCLES OR 40,000 HOURS, WHICHEVER OCCURS FIRST. AFTER REFURBISHMENT AND OVERHAUL, THE CHAMBER IS RE-ASSEMBLED, PRESSURE TESTED, AND VERIFIED IN COMPLIANCE WITH ASME CODE & PVHO SAFETY STANDARDS. AFTER A FACTORY OVERHAUL, THE CYLINDER WILL BE ABLE TO BE UTILIZED FOR UP TO AN ADDITIONAL 10 YEARS SO LONG AS THE PERIODIC CYLINDER INSPECTIONS IN ACCORDANCE WITH PVHO-2 ARE CONDUCTED. 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. 36532.