MALIBU/SOVEREIGN
Received Jun 1, 2026 · Event occurred May 1, 2026
Report 1419652-2026-00096 · MDR key 25353152
Device
Product problems
- Use of Device Problem
Patient
47 YR · Female
- Fall
- Bone Fracture(s)
Narrative
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.