SYSTEM 2000

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z.O.O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS INITIALLY REPORTED THAT BATH WAS TIPPING DURING USE. ARJOHUNTLEIGH REPRESENTATIVE WAS INFORMED BY CAREGIVER THAT PATIENT SEAT ON THE END OF THE BATH AND WAS ACTIVE MOVING ON THIS POINT. PATIENT WAS LEFT WITHOUT CAREGIVER DURING THERAPY.

Additional Manufacturer Narrative

AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR SYSTEM 2000 WE HAVE FOUND A VERY LOW NUMBER OF OTHER SIMILAR CASES - TUB WAS TIPPING DURING USE DUE TO MISUSE. THE DEVICE WAS BEING USED FOR THE PATIENT THERAPY- DURING BATHING PATIENT SEAT ON THE END OF THE TUB AND STARTED TO ACTIVE MOVING. BATH ALMOST TIP OVER, AND IN THAT WAY CONTRIBUTED TO THE EVENT. IT WAS REPORTED BY THE CAREGIVER FROM THE FACILITY THAT PATIENT HAS BEEN LEFT WITHOUT CAREGIVER WHEN THE EVENT OCCURRED. MOREOVER FURTHER EXAMINATION BY ARJOHUNTLEIGH'S REPRESENTATIVE REVEALED NO FAULTS WITHIN A DEVICE - FUNCTION TEST SHOWED THAT THE DEVICE WAS WORKING TO ITS SPECIFICATION. NO REPAIR OR ADJUSTMENT HAS BEEN DONE. THE TECHNICIAN HAS MANAGED TO RECREATE THE EVENT: BATH HAS BEEN FILLED AUTOMATICALLY AND PLACED ON THE HIGHEST POSITION. THE TECHNICIAN APPLIED THEIR FULL WEIGHT ON THE TUB (THE TECHNICIAN'S WEIGHT IS (B)(6)), NOTHING HAPPENED. WHEN THE TECHNICIAN HUNG ON AND MOVED UP AND DOWN VIOLENTLY, THE DEVICE MOVED, IT WAS POSSIBLE TO BE MADE TO RECLINE. ALL DEVICES ARE EQUIPPED WITH INSTRUCTION FOR USE, WHICH CLEARLY INFORM HOW TO CORRECT USE AND MAINTENANCE THE BATH. INSTRUCTION FOR USE FOR SYSTEM 2000 CONTAINS WARNINGS WHICH CLEARLY INFORM THAT: "TO AVOID FALLING, MAKE SURE THE RESIDENT ALWAYS REMAINS IN A SEATED POSITION." "TO AVOID INJURY, ENSURE THAT THE RESIDENT IS NOT LEFT UNATTENDED AT ANY TIME." AFTER REVIEWING THE COMPLAINT IT COMES FORWARD THAT THE DEVICE WAS ACCORDING TO SPECIFICATION WHEN THE EVENT OCCURRED. THE DEVICE WAS IN GOOD WORKING CONDITION, NO FAILURE WAS DETECTED. FROM ABOVE FINDINGS WE CONCLUDE THAT THIS INCIDENT WAS CAUSED BY USER ERROR - THE EVENT OCCUR DUE TO NOT FOLLOWING THE INSTRUCTION FOR USE BY CAREGIVER. PATIENT HAS BEEN LEFT UNATTENDED DURING THERAPY. PERSONNEL FROM FACILITY CONFIRM THAT PATIENT SEAT ON THE EDGE/END OF THE BATH AND WAS ACTIVELY MOVING ON THAT POINT. PLEASE NOTE, THAT IF CAREGIVER WOULD HAVE FOLLOWED EVERY GUIDELINE GIVEN IN INSTRUCTION FOR USE (PATIENT IS NOT LEFT UNATTENDED, AND PATIENT REMAINS IN A SEATED POSITION) THERE WOULD HAVE BEEN NO USER AT RISK.