SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3600E/ER

Additional Manufacturer Narrative

CUSTOMER REPORTED THAT DURING THE START OF THE TREATMENT THAT A LOUD NOISE WAS HEARD AND THE TECH NOTICED THAT THE CHAMBER PRESSURE WAS AT ZERO. CUSTOMER NOTICED THAT THE SAFETY BLOCK WAS LOOSE. NO PATIENT OR USER INJURY 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. DAMAGE TO CHAMBER IS INDICATIVE OF THE CHAMBER DOOR NOT BEING CLOSED COMPLETELY PRIOR TO PRESSURIZING THE CHAMBER. PER USER'S MANUAL, USER TO VISUALLY VERFIY GREEN LOCKING PIN IS ENGAGED WHICH INDICATED DOOR IS COMPLETLY CLOSED 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 REPORTED THAT DURING START OF TREATMENT A LOUD NOISE WAS HEARD AND THE TECH NOTICED THE CHAMBER PRESSURE WAS AT ZERO. CUSTOMER REPORTED THAT THE SAFETY BLOCK WAS LOOSE. NO PATIENT OR USER INJURY REPORTED.