SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3300H/HR

Additional Manufacturer Narrative

CUSTOMER REPORTED TO SECHRIST INDUSTRIES (SI) TECHNICIAN DURING PM SERVICE THAT THE EMERGENCY VENT AND TOGGLE SWITCH WERE NOT CURRENTLY WORKING. NO PATIENT INJURY WAS REPORTED. AFTER THE CHAMBER WAS EVALUATED BY TRAINED SI TECHNICIAN, IT WAS DETERMINED THAT THE TUBING WAS PINCHED ON THE EXHAUST CANNISTER THEREBY PREVENTING FLOW. THE EXHAUST CANNISTER WAS REMOVED AND THE TUBING WAS UN-PINCHED AND THE EXHAUST CANNISTER WAS RE-ATTACHED TO CHAMBER. THE CHAMBER'S EMERGENCY VENT AND TOGGLE SWITCH WERE TESTED AFTER THIS REPAIR AND BOTH WERE CONFIRMED TO BE FUNCTIONING PROPERLY. 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 EMERGENCY VENT AND TOGGLE SWITCH ARE CURRENTLY NOT WORKING. NO PATEINT INJURY WAS REPORTED.