SECHRIST 2800/R MONOPLACE HYPERBARIC CHAMBER

Additional Manufacturer Narrative

THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO NEW INFORMATION HAS BEEN RECEIVED. BASED ON THE AGE OF THE DEVICE, IT IS UNLIKELY 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 (B)(4).

Description of Event or Problem

CUSTOMER REPORTED THE PRESSURE IS NOT RELEASED FROM THE CHAMBER ONLY AFTER CLOSING THE INLET SOURCE, AND WHEN CLOSING THE SOURCE, PRESSURE DROPS QUICKLY WHICH IS NOT RECOMMENDED, PLUS THE EMERGENCY PRESSURE RELEASE IS NOT WORKING TO RELEASE THE PRESSURE FROM THE CHAMBER. NO PATIENT INCIDENT WAS REPORTED.