SEHCRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3300H/HR

Additional Manufacturer Narrative

CHAMBER WAS EVALUATED BY SECHRIST TRAINED TECHNICAN AND DETERMINED THAT THE CAUSE OF THE INCIDENT WAS PREMATURE COMPONENT FAILURE. THE SMC REGULATOR WAS STUCK IN THE OPEN POSITION WHICH CAUSED THE PRESSURE TO INCREASE ON ITS OWN PASSED THE SET PRESSURE. THE SAFETY FEATURES OF THE CHAMBER DID ACTIVATE WHEN THE PRESSURE WENT ABOVE 30 PSIG AS INTENDED. THE OPERATOR CHOSE TO USE THE EMERGENCY VENT TO REMOVE THE PATIENT, WHICH EVACUATES THE CHAMBER IN UNDER 119 SECONDS. THIS RAPID PRESSURE DROP ACCOUNTED FOR THE MINOR PATIENT INJURY (BARATRAUMA). THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY AT THIS TIME. 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 THAT THE CHAMBER WAS COMPRESSED TO 2.0 ATA WITH PATIENT WITHOUT ISSUE AND A SHORT TIME LATER THE CHAMBER OPERATOR HEARD THE SOUND OF THE CHAMBER PRV (PRESSURE RELIEF VALUES) OPENING. WHEN HBO OPERATOR CHECKED, HE DISCOVERED THAT THE CHAMBER HAD COMPRESSED ON ITS OWN PAST 30 PSIG AND WOULD NOT REPSOND TO SET PRESSURE COMMAND WHEN THE PRESSURE WAS DECREASED. THE OPERATOR USED THE EMERGENCY VENT INTERMITTENLY TO BRING THE PATIENT OUT OF THE CHAMBER. PATIENT WAS REPORTED TO HAVE SLIGHT BARAOTRAUMA TO BOTH EARS.