MODEL 3200 HYPERBARIC CHAMBER

Description of Event or Problem

THE FOLLOWING WAS PROVIDED DESCRIPTION OF EVENTS OBTAINED FROM MAUDE ADVERSE EVENT REPORT. PATIENT COMPLETED HYPERBARIC DIVE (119 MINUTES). WHEN REMOVED FROM CHAMBER, BLOOD NOTED IN LEFT EAR CANAL. POSSIBLE RUPTURED EAR DRUM.

Additional Manufacturer Narrative

SERVICE TECHNICIAN SENT TO HOSPITAL TO PERFORM VISUAL INSPECTION AND PERFORMANCE VERIFICATION TO APPROVED FIELD SERVICE PROCEDURES. DURING TESTING OF THE DEVICE, THE TECHNICIAN FOUND THE EMERGENCY VENTILATION RATE FROM A STARTING PRESSURE OF 30 PSIG DOWN TO 0 PSIG WAS NOT THE SPECIFICATION OF <120 SECONDS. THE RECORD TIME WAS 152 SECONDS. THE TECHNICIAN INVESTIGATED THE CAUSE OF THIS OUT-OF-SPECIFICATION CONDITION AND FOUND A RESTRICTIVE END CAP ON THE EXHAUST LINE. THE TECHNICIAN REPLACED THE END CAP WITH THE WIRE MESH SCREEN AS REQUIRED BY THE SECHRIST INDUSTRIES INSTALLATION INSTRUCTIONS. NO PATIENT INFORMATION AVAILABLE AT THIS TIME. FURTHER INFORMATION WILL BE PROVIDED ON FOLLOW-UP ONCE RECEIVED BY MEDICAL CENTER.