SYSTEM 2000

Description of Event or Problem

ARJO WAS NOTIFIED OF AN EVENT INVOLVING A SYSTEM 2000 BATHTUB. IT WAS INDICATED THAT THE RIGHT MOUNTING BOLT DETACHED FROM THE BATHTUB SHELL WHEN THE RESIDENT WAS BEING TRANSFERRED ON A JOERNS HOYER LIFT IN A SLING BY TWO CAREGIVERS. THE RESIDENT PLACED FEET AGAINST THE TUB SHELL, AND THE TUB TILTED TO THE RIGHT SIDE, RESULTING IN WATER SPILLING ONTO THE FLOOR. 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

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

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE RIGHT BOLT (LOOKING AT THE FRONT OF THE BATHTUB PANEL) HOLDING THE BATHTUB SHELL DETACHED FROM ITS CONNECTION POINT WHILE THE RESIDENT (WHO WAS SITTING IN THE SLING ON THE LIFT) LEANED FEET AGAINST THE BATHTUB SHELL. THE BOLT'S DETACHMENT LED TO THE CRACKING OF THE TUB'S LAMINATE AND ITS TIPPING. THIS RESULTED IN WATER SPILLING ONTO THE FLOOR. NO INJURIES WERE REPORTED. THE DEVICE INSPECTION PERFORMED BY ARJO REPRESENTATIVES REVEALED THAT THE CONDITION OF THE BATHTUB WAS POOR. IT WAS SUGGESTED BY ONE OF THE ARJO REPRESENTATIVE THAT THE MOUNTING BOLT COULD DETACH FROM THE TUB SHELL AS WAS POSSIBLY INSTALLED INCORRECTLY YEARS AGO WHEN THE BATH WAS ORIGINALLY INSTALLED. NO PHOTOS WERE PROVIDED SHOWING THE DETACHED BOLT AND THE LOCATION WHERE THE BOLT IS USUALLY SCREWED IN. THE BATHTUB WAS DISPOSED OF AND IT WAS NOT POSSIBLE TO EVALUATE THE ISSUE FURTHER. NEVERTHELESS, THE PREVENTIVE MAINTENANCE AND ROUTINE INSPECTIONS PERFORMED ANNUALLY AS REQUIRED BY THE MANUFACTURER SHOULD DETECT A HYPOTHETICAL INCORRECTLY INSTALLED BOLT. BASED ON THE INFORMATION GATHERED ARJO PERFORMED SERVICE FOR THE INVOLVED DEVICE UPON CUSTOMER REQUEST, HOWEVER, THE CUSTOMER HAS NO ANNUAL PREVENTATIVE MAINTENANCE (PM) AGREEMENT WITH ARJO. THE SYSTEM 2000 BATH INSTRUCTIONS FOR USE (IFU; 04.AR.12_1) STATES: "ACTION BEFORE EVERY USE: 1. CHECK THAT ALL PARTS ARE IN PLACE. (...) 2. CHECK BATH AND ACCESSORIES FOR DAMAGE." ¿SYSTEM 2000 HAS TO BE SERVICED ACCORDING TO THE PREVENTIVE MAINTENANCE SCHEDULE (QUALIFIED PERSONNEL ACTION/CHECK).¿ THE SYSTEM 2000 BATH MUST BE SERVICED ONCE A YEAR IN ACCORDANCE WITH THE MAINTENANCE AND REPAIR MANUAL. THE MAINTENANCE AND REPAIR MANUAL FOR SYSTEM 2000 (09.AR.07_13) INFORMS THE USER THAT: ¿THE FOLLOWING ACTIONS MUST BE CARRIED OUT BY QUALIFIED PERSONNEL, USING CORRECT TOOLS AND KNOWLEDGE OF PROCEDURES. FAILURE TO MEET THESE REQUIREMENTS COULD RESULT IN PERSONAL INJURIES AND/OR UNSAFE PRODUCT." AND IN SECTION ¿LOCKING, LUBRICATION AND TORQUE¿ PROVIDES REQUIREMENT TO CHECK THE SCREWS IN QUESTION DURING THE ANNUAL MAINTENANCE AND TO TIGHTEN THEM IF NECESSARY. IN SUMMARY, THE RIGHT MOUNTING BOLT 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 AND IN THAT WAY IT PLAYED A ROLE IN THIS EVENT. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO THE COMPETENT AUTHORITIES DUE TO INFORMATION THAT TUB SHELL STARTED TO DETACH DURING USE.