MALIBU/SOVEREIGN

Description of Event or Problem

ARJO WAS NOTIFIED OF AN EVENT INVOLVING A MALIBU BATHTUB. IT WAS REPORTED THAT THE BATHTUB TIPPED OVER WHEN THE RESIDENT WAS SITTING ON THE BATH CHAIR (AN INTEGRAL PART OF THE BATHTUB). IT WAS INDICATED THAT WHILE SUPPORTING THE RESIDENT'S LEGS, THE BATH CHAIR BEGAN TO LOWER. A LOUD NOISE WAS HEARD AND THE RESIDENT FELL TO THE GROUND. NO INJURIES WERE SUSTAINED BY THE RESIDENT.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ARJO WAS NOTIFIED OF AN EVENT INVOLVING A MALIBU BATHTUB. IT WAS REPORTED THAT THE BATHTUB TIPPED OVER WHEN THE RESIDENT WAS SITTING ON THE BATH CHAIR (AN INTEGRAL PART OF THE BATHTUB). IT WAS INDICATED THAT WHILE SUPPORTING THE RESIDENT'S LEGS, THE BATH CHAIR BEGAN TO LOWER. A LOUD NOISE WAS HEARD AND THE RESIDENT FELL TO THE GROUND. NO INJURIES WERE SUSTAINED BY THE RESIDENT. THE DEVICE WAS INSPECTED BY AN ARJO REPRESENTATIVE. ALL OPERATIONAL FUNCTIONS OF THE BATH WERE WORKING CORRECTLY. IT WAS NOTED THAT THE TUB FOOT ATTACHMENT OPPOSITE THE CHAIR WAS BENT AND NO LONGER HELD THE TUB FOOT IN PLACE. FOR THIS REASON, THE BATHTUB SLIPPED OUT OF ITS MOUNT AND FELL OVER. 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 MALIBU BATH INVOLVED IN THE EVENT WAS MANUFACTURED ABOUT 12 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 MALIBU BATH (04.AZ.00_8): ¿THE EXPECTED LIFE OF THIS EQUIPMENT, UNLESS OTHERWISE STATED, IS TEN (10) YEARS, SUBJECT TO PREVENTIVE MAINTENANCE BEING CARRIED OUT IN ACCORDANCE WITH THE CARE AND PREVENTIVE MAINTENANCE FOUND IN THE IFU.¿ ADDITIONALLY, THE IFU IN THE SECTION "CARE AND PREVENTIVE MAINTENANCE" INCLUDES THE CAREGIVER'S OBLIGATIONS TO CHECK THE BATH MECHANICAL ATTACHMENTS ON WEEKLY BASIS. DUE TO MALFUNCTION REPORTED, THE BATHING SYSTEM DID NOT MEET THE PERFORMANCE SPECIFICATION. THE BATH WAS USED WITH THE RESIDENT WHEN THE EVENT OCCURRED. THE COMPLAINT WAS DECIDED TO BE REPORTABLE TO THE COMPETENT AUTHORITIES DUE TO THE BATHTUB TIPPING OVER, WHICH LED TO THE RESIDENT'S FALL.