SYSTEM 2000

Description of Event or Problem

ARJO WAS NOTIFIED OF AN EVENT INVOLVING A SYSTEM 2000 BATHTUB. IT WAS INDICATED THAT ONE OF THE TWO BOLTS DETACHED FROM THE BATHTUB SHELL WHILE THE RESIDENT WAS TAKING A BATH. NO INJURIES WERE REPORTED.

Additional Manufacturer Narrative

PROCESS OF COLLECTING AND ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

Additional Manufacturer Narrative

ARJO WAS NOTIFIED OF AN EVENT INVOLVING A SYSTEM 2000 BATHTUB. IT WAS INDICATED THAT ONE OF THE TWO BOLTS DETACHED FROM THE BATHTUB SHELL WHILE THE RESIDENT WAS TAKING A BATH. NO INJURIES WERE REPORTED. THE INSPECTION CARRIED OUT BY AN ARJO REPRESENTATIVE REVEALED THAT THE BATHTUB SHELL WAS PARTIALLY DETACHED FROM THE BASE, AND THE BATHTUB LAMINATE WAS CRACKED IN ONE SPOT. IT WAS NOTED THAT ONE OF THE TWO MOUNTING SCREWS HAD DETACHED FROM THE BATHTUB SHELL. HOWEVER, THE BATHTUB SHELL DID NOT TIP OVER AND REMAINED SECURELY ATTACHED TO THE BASE PANEL AT ALL TIMES BY THE SECOND SCREW AND TWO HOOKS ON THE PILLAR. ACCORDING TO THE SYSTEM 2000 INSTRUCTIONS FOR USE (IFU; 04.AR.12_19EN), THE BATH MUST BE SERVICED ANNUALLY IN ACCORDANCE WITH THE MAINTENANCE AND REPAIR MANUAL. THE MAINTENANCE AND REPAIR MANUAL (09.AR.07_14EN) SPECIFIES THAT MECHANICAL ATTACHMENTS SHOULD BE CHECKED EVERY YEAR: "CHECK: TUB AND PANEL FITTINGS: TUB TO BRACKET ATTACHMENT SHALL BE "CHECKED FOR TORQUE EVERY YEAR." BASED ON THE INFORMATION RECEIVED, THE BATH WAS SERVICED BY ARJO UPON THE CUSTOMER'S REQUEST. THE BATHTUB WAS UNDER AN ARJO SERVICE CONTRACT PRIOR TO THE REPAIR PERFORMED IN JUNE 2024. THE REPORTED MALFUNCTION WAS DISCUSSED WITH THE MANUFACTURER TO DETERMINE THE POSSIBLE CAUSE OF THE FAILURE. SEVERAL POTENTIAL CAUSES FOR THE SCREW DETACHMENT WERE IDENTIFIED: 1. IMPROPER INSTALLATION OF THE TUB ¿ THE LAMINATE WAS NOT FULLY SECURED ON ONE SIDE, AND OVER TIME, DUE TO THE UP-AND-DOWN MOVEMENT, THE SCREW FINALLY FELL OUT. 2. CONTAMINATION INSIDE THE BUSHING ¿ SUBSTANCES SUCH AS PAINT, RESIN, OR GLUE MAY HAVE BEEN PRESENT, POTENTIALLY LEADING TO THREAD DAMAGE INSIDE THE BUSHING WHEN THE SCREW WAS INSERTED. 3. MECHANICAL DAMAGE TO THE THREAD ¿ EITHER THE SCREW OR THE BUSHING (WHICH IS GLUED INTO THE LAMINATE) MAY HAVE BEEN DAMAGED. IN THIS CASE, THE SCREW MAY HAVE BEEN FORCIBLY SCREWED IN, CAUSING THE THREADS TO BREAK AND BECOME DAMAGED OVER TIME. THE THREADED BUSHINGS IN THE TUB SHELL ARE OF CONSIDERABLE LENGTH. PROPERLY MADE THREADS AND NOT DAMAGING THEM DURING INSTALLATION ENSURES THAT THERE IS NO POSSIBILITY FOR THE TUB SHELL TO UNSCREW. AS DEFECTIVE PARTS WERE REPLACED, IT WAS NOT POSSIBLE TO CONCLUSIVELY DETERMINE WHICH OF THE ABOVE SCENARIOS OCCURRED. IN SUMMARY, THE MOUNTING SCREW DETACHED FROM THE BATHTUB SHELL AND THE BATH LAMINATE CRACKED, SO THE DEVICE DID NOT PERFORM AS INTENDED. THE BATHTUB WAS USED FOR PATIENT HYGIENE. THIS COMPLAINT WAS INITIALLY CONSIDERED REPORTABLE TO THE COMPETENT AUTHORITIES DUE TO INFORMATION INDICATING THAT THE TUB SHELL HAD STARTED TO DETACH DURING USE. HOWEVER, BASED ON THE INFORMATION GATHERED DURING THE COURSE OF THE INVESTIGATION AND REVIEW OF PREVIOUS COMPLAINTS, IT WAS DETERMINED THAT, IN THE WORST-CASE SCENARIO, THE CLAIMED MALFUNCTION CAN RESULT IN A DIAGONAL BEND AND A SLIGHT SIDEWAYS MOVEMENT OF THE TUB SHELL. IT WAS ESTABLISHED THAT THIS TYPE OF MALFUNCTION HAS NOT CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY IN THE PAST. THEREFORE, THE COMPLAINT REPORTED DOES NOT MEET THE REPORTING CRITERIA AND SUCH FAILURE WILL NOT BE REPORTED IN THE FUTURE.

Additional Manufacturer Narrative

PROCESS OF COLLECTING AND ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.