MALIBU/SOVEREIGN

Additional Manufacturer Narrative

PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DEACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE NOT TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. NO UDI INFORMATION IS AVAILABLE; THE DEVICE WAS MANUFACTURED BEFORE UDI IMPLEMENTATION.

Description of Event or Problem

ARJO WAS NOTIFIED OF AN INCIDENT INVOLVING A MALIBU BATH. IT WAS REPORTED THAT, WHILE CAREGIVERS WERE LIFTING A RESIDENT OUT OF THE BATH, THE RESIDENT MOVED AND FELL FROM THE MALIBU BATH CHAIR. AS A RESULT OF THE FALL, THE PATIENT REPORTEDLY SUSTAINED A HAIRLINE FRACTURE TO THE RIGHT HEEL, WHICH WAS CONFIRMED BY X-RAY. MEDICAL INTERVENTION WAS REQUIRED, INCLUDING THE APPLICATION OF A CAST, WHICH HAS SINCE BEEN REMOVED. THE DEVICE WAS INSPECTED BY AN ARJO SERVICE TEAM LEADER. IT WAS CONFIRMED THAT THE BATH REMAINS IN USE AND IS IN GOOD WORKING CONDITION. IT WAS ALSO NOTED THAT THE BATH IS NOT EQUIPPED WITH A SAFETY BELT.