SYSTEM 2000

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING AND FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

ARJO WAS NOTIFIED OF AN EVENT INVOLVING A SYSTEM 2000 BATHTUB. THE BATHTUB WAS BEING FILLED. CAREGIVERS WERE ATTACHING A RESIDENT TO A CEILING LIFT THAT WAS ABOVE THE TUB. THE CAREGIVER HEARD A CREAK, AFTER WHICH THE SYSTEM 2000 BATHTUB SHELL TILTED ONTO THE CAREGIVER'S HIP AND BACK. THE CAREGIVER REMAINED AT WORK FOR ABOUT TWO MORE HOURS, AFTER WHICH WENT TO HOSPITAL FOR EXAMINATION. THE CAREGIVER EXPERIENCED GENERAL SORENESS THROUGHOUT THE BODY, BUT THERE WERE NO BRUISES OR BROKEN BONES. WHEN THE DEVICE WAS INSPECTED, THE SCREW OF THE BACK LEG ON THE RIGHT SIDE OF THE TUB WAS FOUND TO BE SHEARED OFF.

Additional Manufacturer Narrative

ARJO WAS NOTIFIED OF AN EVENT INVOLVING A SYSTEM 2000 BATHTUB. THE BATHTUB WAS BEING FILLED. CAREGIVERS WERE ATTACHING A RESIDENT TO A CEILING LIFT THAT WAS ABOVE THE TUB. THE CAREGIVER HEARD A CREAK, AFTER WHICH THE SYSTEM 2000 BATHTUB SHELL TILTED ONTO THE CAREGIVER'S HIP AND BACK. THE CAREGIVER REMAINED AT WORK FOR ABOUT TWO MORE HOURS, AFTER WHICH WENT TO HOSPITAL FOR EXAMINATION. THE CAREGIVER EXPERIENCED GENERAL SORENESS THROUGHOUT THE BODY, BUT THERE WERE NO BRUISES OR BROKEN BONES. THE DEVICE WAS INSPECTED BY AN ARJO SERVICE TECHNICIAN. IT WAS FOUND THAT THE SCREW OF THE BACK LEG ON THE RIGHT SIDE OF THE TUB WAS SNAPPED. BASED ON THE DEVICE INSPECTION RESULTS, THE POST-MARKET SURVEILLANCE DATA AND CONSULTATION WITH THE ARJO TECHNICAL DEPARTMENT, WE CAME TO THE CONCLUSION THAT THE ISSUE REPORTED SEEMS TO BE RELATED TO NORMAL WEAR OF THE COMPONENT. THE SYSTEM 2000 BATH INVOLVED IN THE EVENT WAS MANUFACTURED ABOUT 19 YEARS BEFORE THIS MALFUNCTION OCCURRED. THE EQUIPMENT IS SUBJECT TO WEAR AND TEAR, AND RECOMMENDED MAINTENANCE INSTRUCTIONS MUST BE PERFORMED WHEN SPECIFIED TO ENSURE THAT THE EQUIPMENT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION. FOLLOWING THE INSTRUCTION FOR USE (IFU) FOR SYSTEM 2000 BATH (04.AR.09/1 GB): "THE NORMAL USEFUL LIFE OF THIS EQUIPMENT, UNLESS OTHERWISE STATED, IS TEN (10) YEARS, SUBJECT TO REQUIRED PREVENTIVE MAINTENANCE AS SPECIFIED IN THE OPERATING AND DAILY MAINTENANCE INSTRUCTION". DUE TO MALFUNCTION REPORTED, THE SYSTEM 2000 BATH DID NOT MEET THE PERFORMANCE SPECIFICATION. THE BATH WAS USED WITH THE RESIDENT WHEN THE EVENT OCCURRED. THIS COMPLAINT WAS DECIDED TO BE REPORTED DUE TO BATH TIPPING OVER DURING USE.