HYPERBARIC CHAMBER

Additional Manufacturer Narrative

EVALUATION FOUND THAT THE RATE KNOB ON THE SHAFT HAD TURNED A LITTLE AND WAS NOT TIGHT. CONFIRMED CHAMBER WAS FOUND TO BE RUNNING AT A RATE OF 1PSI BELOW SPECIFICATION. TECHNICIAN BROUGHT THE CHAMBER BACK INTO SPECIFICATION. SECHRIST CHAMBER USER'S MANUAL STATES THAT A CHAMBER COMPRESSING/DECOMPRESSING AT A RATE SLOWER THAN SPECIFICATION, ALLOWS THE PATIENT EXTRA TIME TO ACCLIMATE TO THE PRESSURE RESULTING IN INCREASED TIME FOR CAVITY EQUALIZATION (IE. EAR PRESSURE). THE RISK IS MITIGATED TO THE LOWEST REASONABLE LEVEL THROUGH LABELING AND/OR INSTRUCTIONS IN THE USER'S MANUAL. SECHRIST RECOMMENDS COMPLETING DAILY, WEEKLY AND SEMI-ANNUAL PERFORMANCE VERIFICATION ON THE CHAMBER TO DETECT ANY ISSUES AND PRECLUDE THE DEVICE FROM USE. IN INSTANCES WHERE THE CHAMBER IS FOUND TO FUNCTION OUTSIDE OF SPECIFICATION, SECHRIST SHOULD BE IMMEDIATELY NOTIFIED FOR TECHNICAL ASSISTANCE. DEVICE HISTORY RECORD REVIEW OF CHAMBER MODEL 3300H/HR SN (B)(4) WAS MANUFACTURED ON 07/23/2012. THERE IS NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NON-CONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. SECHRIST REFERENCE INCIDENT NUMBER (B)(4).

Description of Event or Problem

AS CUSTOMER REPORTED THAT THE PATIENT STARTED HAVING SEIZURE LIKE SYMPTOMS DURING THE ASCENT PHASE AT 1.6 ATA, DURING THAT TIME THE TREATING PHYSICIAN WAS CALLED TO ASSIST THE HBO TECH AND WAS ORDERED TO CONTINUE ASCENDING AND REMOVE THE PATIENT. STAFF STATED THAT THE CHAMBER TOOK 12 MINUTES AT 1.6 PSI TO OPEN THE DOOR AND REMOVE THE PATIENT. CLINIC WOULD LIKE TIMING CHECKED ON CHAMBER TO SEE IF IT IS IN SPECIFICATION. PATIENT WAS EXAMINED BY THE ER PHYSICIAN AND THE DIAGNOSES WAS PATIENT WAS HAVING ELEVATED ST WAVES VIA AN EKG AND A MYOCARDIAL INFARCTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS BEING FOLLOWED UP FOR CARDIAC INTERVENTION AND STENT PLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED TO SECHRIST FROM FACILITY'S CLINICAL HBO TECH, WHO STATED THAT THE PATIENT HAD A STENT PLACED IN THE CATH LAB AND WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION AND WAS CLEARED TO RETURN TO HBO. THE PATIENT WAS RETURNED BACK TO HBO FOR TREATMENTS WITHOUT ISSUE.