SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3200

Description of Event or Problem

CUSTOMER IS REPORTING THAT THE CHAMBER EMERGENCY VENT IS NOT WORKING THEREBY NOT ALLOWING THE CHAMBER TO PERFORM AN EMERGENCY DECOMPRESSION. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

EVALUATION OF CHAMBER AT USER FACILITY BY SECHRIST INDUSTRIES, INC. SERVICE TECHNICIAN CONFIRMED THE REPORTED CUSTOMER ISSUE OF THE EMERGENCY VENT NOT FUNCTIONING. THE CHAMBER REQUIRED A NEW SUPPLY ACTUATOR TO BE INSTALLED. AFTER INSTALLING NEW PART, THE EMERGENCY VENT WAS TESTED AND VERIFIED TO BE FUNCTIONING PROPERLY AND WITHIN SPECIFICATIONS. BASED ON THE AGE OF THE DEVICE, THE ROOT CAUSE CAN BE LIKELY ATTRIBUTED TO NORMAL WEAR AND TEAR OF THE COMPONENT. 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 PREVENTIVE 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).