SECHRIST MONOPLACE HYPERBARIC CHAMBER-MODEL 3200/R

Additional Manufacturer Narrative

AFTER CHAMBER EVALUATED BY TRAINED SECHRIST TECHNICAIN, IT WAS DISCOVERED THAT THE EMERGENCY VENT BUTTON ACTUATOR NEEDED TO BE REPLACED. THE INVOLVED CHAMBER IS OVER 12 YEARS OLD AND THE FAILURE IS DUE TO NORMAL WEAR AND TEAR. NO PATIENT INVOLVEMENT OR INCIDENT WAS REPORTED. 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 ASESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO.: (B)(4).

Description of Event or Problem

CUSTOMER IS REPORTING THAT THE EMERGENCY VENT BUTTON IS NOT WORKING TO EMERGENCY VENT THE CHAMBER. NO PATIENT INCIDENT WAS REPORTED.