SECHRIST 3600H/HR HYPERBARIC OXYGEN CHAMBER

Additional Manufacturer Narrative

EVALUATION OF THE DEVICE FOUND THE EMERGENCY VENT WAS OUT OF SPECIFICATION AND TAKING LONGER THAN 120 SECONDS TO REACH THE SURFACE FROM 3 ATA. UPON INSPECTION OF THE CHAMBER THE IDEAL PRESSURE REGULATOR CAP WAS SLIGHTLY LOOSE, ALSO CAUSING THE CHAMBER, DURING USE, TO DECOMPRESS BACK TO THE SURFACE WITHOUT STOPPING AT IDLE PRESSURE AND RETURNING TO THE SURFACE WHEN THE CHAMBER WAS STILL RUNNING. PERFORMED A VISUAL INTERNAL INSPECTION OF THE IDLE PRESSURE REGULATOR, REASSEMBLED AND ADJUSTED IDLE PRESSURE TO 1.5 PSI AT A RATE OF THREE OF 275 LPM. CHAMBER WAS RE-PRESSURIZED BACK TO 3 ATA AND EMERGENCY DECOMPRESSION TEST WAS PERFORMED. CHAMBER WAS FOUND TO BE IN SPEC WITH A TIME OF 93 SECONDS TO OPEN DOOR. 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 FILE NO. (B)(4).

Description of Event or Problem

CUSTOMER REPORTED THE EMERGENCY VENT BUTTON IS NOT WORKING DURING WEEKLY TEST, BUT THE EMERGENCY TOGGLE SWITCH WILL WORK AND IS IN SPEC, CHAMBER IS STILL IN SERVICE. NO PATIENT INCIDENT WAS REPORTED.