SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3200/R

Additional Manufacturer Narrative

CUSTOMER REPORTED THAT THE LOCKING PIN IS NOT FULLY ENGAGING INTO LOWER SWING ARM TO SHOW DOOR LOCK INDICATOR. NO PATIENT/USER INJURY WAS REPORTED. CHAMBER WAS EVALUATED BY SECHRIST TRAINED TECHNICIAN AND FOUND THE SAFETY BLOCK WAS NOT ALIGNED PROPERLY. THE CAUSE OF THE MISALIGNMENT COULD NOT BE CONCLUSIVELY DETERMINED. AFTER SAFETY BLOCK WAS ALIGNED, THE LOCKING PIN AND THE DOOR LOCK INDICATOR FUNCTIONED AS INTENDED. PER USER'S MANUAL, USER TO VISUALLY VERFIY GREEN LOCKING PIN IS ENGAGED PRIOR TO PRESSURIZING CHAMBER. 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 REPORTING THAT THE LOCKING PIN IS NOT FULLY ENGAGING INTO THE LOWER SWING ARM TO SHOW THE DOOR LOCK INDICATOR. NO PATIENT/USER INJURY WAS REPORTED.