MALIBU/SOVEREIGN
Received Oct 21, 2024 · Event occurred Sep 1, 2024
Report 3007420694-2024-00266 · MDR key 20491014
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 MALIBU BATHTUB. IT WAS REPORTED THAT THE BATHTUB WAS NOT SECURED TO THE FLOOR. IT WAS INDICATED THAT WATER HAD ENTERED THE BATHTUB'S FLOOR ATTACHMENT, CAUSING THE BATHTUB FIXING TO DETACH. . THE WOODEN FLOOR IN THIS AREA WAS ROTTEN. NO PATIENT WAS INVOLVED AND NO INJURIES WERE REPORTED. THE BATHTUB WAS TAKEN OUT OF USE.
Additional Manufacturer Narrative
ARJO WAS REQUESTED FOR SERVICE OF THE MALIBU BATH. THE DEVICE WAS EVALUATED BY AN ARJO REPRESENTATIVE. IT WAS NOTED THAT THE BATH WAS NOT SECURED TO THE FLOOR. IT WAS INDICATED THAT WATER HAD ENTERED THE BATHTUB'S FLOOR ATTACHMENT, CAUSING THE BATHTUB FIXING TO DETACH. THE WOODEN FLOOR IN THIS AREA WAS ROTTEN. NO PATIENT WAS INVOLVED AND NO INJURIES WERE REPORTED. THE BATHTUB WAS TAKEN OUT OF USE. NO MALFUNCTION OF THE BATH WAS REPORTED THAT MAY HAVE CONTRIBUTED TO THE EVENT. ACCORDING TO THE DEVICE INSPECTION RESULTS AND PHOTO EVIDENCE PROVIDED THE BATH ATTACHMENT HAD BEEN TORN OUT OF THE FLOOR DUE TO ROTTEN WOODEN FLOOR. THE INSPECTION REVEALED NO LEAKS FROM THE BATH. THEREFORE, IT IS LIKELY THE CAUSE OF THE EVENT WAS THE DAMAGED FLOOR, WHICH ALLOWED THE BATH TO MOVE OUT OF THE REQUIRED POSITION. THE MALIBU INSTRUCTION FOR USE (04.AZ.00_8GB) INCLUDES THE CAREGIVER OBLIGATIONS, INTER ALIA THE ONE RELATED TO THE MECHANICAL ATTACHMENTS SUCH AS FLOOR FIXTURES TO BE CHECKED ON A WEEKLY BASIS: ¿CHECK MECHANICAL ATTACHMENTS: CHECK THAT ALL SCREWS AND NUTS ARE TIGHTENED AND THAT THERE ARE NO GAPS.¿ "ACTIONS BEFORE EVERY USE (...) 2. CHECK BATH AND ACCESSORIES FOR DAMAGE. 3 IF ANY PART IS MISSING OR DAMAGED - DO NOT USE THE PRODUCT." IN SUMMARY, THE BATH DETACHED FROM THE FLOOR AND FROM THAT PERSPECTIVE, THE DEVICE DID NOT PERFORM AS INTENDED. THE MALIBU BATH WAS NOT USED FOR A PATIENT HANDLING AT THE TIME OF THE EVENT. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO COMPETENT AUTHORITIES DUE TO INDICATION OF MALFUNCTION (BATH NOT SECURED TO THE FLOOR), WHICH MAY LEAD TO THE PATIENT FALL AND RESULT IN AN INJURY OCCURRENCE.