SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3200/R

Additional Manufacturer Narrative

THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. CHAMBER HAS NOT BEEN EVALUATED AT THIS TIME AS WAITING FOR FACILITY TO SCHEDULE SERVICE. THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME TO VERIFY OR CONTRADICT THE REPORTED CUSTOMER ISSUE. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS FOR THE SAFE AND EFFECTIVE USE OF THIS DEVICE. 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 IS REPORTING THAT THE EMERGENCY DECOMPRESSION TIME IS FALLING OUT OF SPECIFICATION GOING OVER TWO (2) MINUTES TO REACH THE SURFACE FROM 3 ATA DURING SCHEDULED TESTING. THE CHAMBER WAS TESTED WITH THE EXHAUST DISCONNECTED FROM THE WALL AND IT IS UNDER TWO (2) MINUTES. THE VENT LINE WAS CHECKED AND REPORTED TO BE CLEAN WITH NO BLOCKAGE PRESENT. NO PATIENT INJURY HAS BEEN REPORTED.