SECHRIST MONOPLACE HYPERBARIC CHAMBER MODEL 3600H/HR

Additional Manufacturer Narrative

EVALUATION OF THE DEVICE FOUND CHAMBER WITH DOOR LOCK ASSEMBLY UNABLE TO FULLY ENGAGE. CUSTOMER REPORTED THEY DO NOT REMEMBER CHECKING THE DOOR ARROW INDICATORS WERE ALIGNED OR THAT THE GREEN SAFETY PIN WAS EXTRACTED AT IDLE PRESSURE BEFORE CONTINUING WITH THE PRESSURE TEST AT TIME OF EVENT. CHAMBER DOOR TOP CAP PIN WAS FOUND BENT AND IN NEED OF REPLACEMENT IN ORDER TO RESTORE PROPER FUNCTIONING OF DOOR LOCK SYSTEM. DOOR SWING ARM ASSEMBLY TOP CAP WAS REPLACED, TESTED AND VERIFIED TO FUNCTION AS DESIGNED. VERIFIED THE DOOR LOCK INDICATOR FUNCTIONED AS EXPECTED. PRESSURIZED CHAMBER TO 3 ATA AND FOUND NO FAULTS IN CHAMBER FUNCTION. BASED ON THE SERVICE FINDINGS, THE MOST PROBABLE ROOT CAUSE IS THAT THE CHAMBER DOOR WAS NOT SECURELY CLOSED BEFORE PRESSURIZING THE DEVICE. A DHR REVIEW FOUND 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 CHAMBER DOOR OPENED AT 5 PSI DURING DAILY STARTUP AND CHECK. NO PATIENT INJURY WAS REPORTED. CUSTOMER WOULD LIKE THE CHAMBER CHECKED.