SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3300H/HR

Description of Event or Problem

THIS IS FOLLOW UP # 1 TO PROVIDE ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

ISSUE WAS RESOLVED BY USER TROUBLE SHOOTING WITH TRAINED SECHRIST INDUSTRIES TECHNICIAN. IT WAS DISCOVERED THAT THE TUBING WAS PINCHED BETWEEN THE CONTROL PANEL AND THE CHAMBER CHASSIS FROM WHEN THE CONTROL PANEL WAS LAST OPENED. THE CHAMBER WAS TESTED BY THE USER AND VERIFIED THAT THE EMERGENCY VENT TOGGLE SWITCH IS NOW FUNCTIONING AS INTENDED. MANUFACTURER REFERENCE FILE NO.: (B)(4).

Additional Manufacturer Narrative

THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. CHAMBER HAS NOT BEEN EVALUATED AT THIS TIME. 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 VENT TOGGLE SWITCH IS NOT WORKING DURING WEEKLY TESTING. NO PATIENT INVOLVEMENT REPORTED.