MALIBU/SOVEREIGN

Description of Event or Problem

ARJO WAS INFORMED ABOUT AN INCIDENT INVOLVING MALIBU BATH. THERE WAS NO INJURY REPORTED. ACCORDING TO THE INFORMATION PROVIDED, PATIENT WAS SEATED IN THE BATH CHAIR AND WAS BEING TRANSFERRED OUT OF THE BATH. THE CHAIR WAS PLACED ON TRANSFER CHASSIS. AT THE FLOOR LEVEL, THE CHAIR WAS DETACHED BY THE CAREGIVER FROM THE LIFT ARM. THEN, CAREGIVER WENT TO MOVE THE PATIENT BY PULLING THE ARMREST OF THE CHAIR. THE CHAIR BECAME DETACHED FROM THE TRANSFER CHASSIS (THE CLIP ON THE SEAT DISENGAGED FROM THE CHAIR FRAME). THE CHAIR STARTED TO SLIP TOWARDS THE CAREGIVER, AND THE TRANSFER CHASSIS STARTED TO SLIP IN THE OTHER DIRECTION. THE CAREGIVER WAS ABLE TO PREVENT PATIENT FROM FALLING. PATIENT WAS PLACED ON THE SLING AND TRANSFERRED TO THE WHEELCHAIR USING OTHER DEVICE.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

Additional Manufacturer Narrative

PROCESS OF ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

Additional Manufacturer Narrative

ARJO WAS INFORMED ABOUT AN INCIDENT INVOLVING MALIBU BATH. THERE WAS NO INJURY REPORTED. ACCORDING TO THE INFORMATION PROVIDED, A PATIENT WAS SEATED IN THE BATH CHAIR AND WAS BEING TRANSFERRED OUT OF THE BATH. THE CHAIR WAS PLACED ON TRANSFER CHASSIS. AT THE FLOOR LEVEL, THE CHAIR WAS DETACHED BY THE CAREGIVER FROM THE LIFT ARM. THEN, CAREGIVER WENT TO MOVE THE PATIENT BY PULLING THE ARMREST OF THE CHAIR. THE CHAIR BECAME DETACHED FROM THE TRANSFER CHASSIS (THE CLIP ON THE SEAT DISENGAGED FROM THE CHAIR FRAME). THE CHAIR STARTED TO SLIP TOWARDS THE CAREGIVER, AND THE TRANSFER CHASSIS STARTED TO SLIP IN THE OTHER DIRECTION. THE CAREGIVER WAS ABLE TO PREVENT PATIENT FROM FALLING. THE PATIENT WAS PLACED ON THE SLING AND TRANSFERRED TO THE WHEELCHAIR USING OTHER DEVICE. THE ARJO REPRESENTATIVE INDICATED THAT THE ISSUE MIGHT BE A RESULT OF USAGE ERROR. LOOKING AT THE PRODUCT INSPECTION (NO MALFUNCTION FOUND) AND POSITIVE TESTING RESULTS OF CONNECTION BETWEEN MALIBU CHAIR WITH TRANSFER CHASSIS, WE CAME TO THE CONCLUSION THAT THE INCORRECT ATTACHMENT OF THE CHAIR WAS THE MOST PROBABLE CAUSE OF THE EVENT, WHICH IS IN LINE WITH THE ARJO REPRESENTATIVE SUGGESTION. THE MALIBU INSTRUCTION FOR USE (IFU; 04.AZ6.03) INCLUDES INFORMATION ON HOW TO USE THE DEVICE: "LIFT THE TRANSFER CHASSIS UP AND SLIDE IT INTO THE TWO RAILS LOCATED UNDERNEATH THE TRANSFER CHAIR." "MAKE SURE THE SPRING LOADED CATCH IN THE BACK OF THE CHAIR CLICKS INTO PLACE. LISTEN FOR THE CLICK SOUND WHEN INSERTING THE TRANSFER CHASSIS." " WIGGLE TO TRANSFER CHASSIS BACK AND FORTH TO MAKE SURE IT¿S SECURELY ATTACHED. CONTINUE LOWERING THE CHAIR". THE IFU ALSO INCLUDES SUPPORTING ILLUSTRATIONS PRESENTING HOW TO CONNECT AND DISCONNECT THE TRANSFER CHAIR WITH THE TRANSFER CHASSIS. BASED ON THE PERFORMED INVESTIGATION THE MOST PROBABLE CAUSE OF EVENT IS RELATED TO THE CHAIR NOT ATTACHED TO THE TRANSFER CHASSIS. IN SUMMARY, NO TECHNICAL FAILURE OF THE BATH WAS FOUND DURING DEVICE INSPECTION. THE DEVICE TRANSFER CHAIR WAS REPORTED TO SEPARATE FROM THE TRANSFER CHASSIS, MOST LIKELY BECAUSE IT WAS NOT ATTACHED TO THE TRANSFER CHASSIS, AND THEREFORE FROM THIS PERSPECTIVE, THE BATHING SYSTEM DID NOT MEET THE PERFORMANCE SPECIFICATION. THE BATH WAS USED FOR PATIENT HYGIENE AND IN THAT WAY IT PLAYED A ROLE IN THIS EVENT.