MALIBU

Additional Manufacturer Narrative

AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ARJOHUNTLEIGH RECEIVED INFORMATION ABOUT AN INCIDENT THAT OCCURRED IN THE (B)(6). ACCORDING TO THE INFORMATION THAT HAS BEEN PRESENTED BY THE CUSTOMER, DURING THE BATHING PROCEDURE THE RESIDENT WAS SEATING ON THE MALIBU BATH CHAIR. WHILE STANDING, HIS SCROTUM WAS NIPPED BETWEEN THE SEAT MOULDING AND THE SEAT FRAME CAUSING A SMALL CUT TO THE SKIN. THE WOUND WAS CHECKED AND CLEANED, NO FURTHER TREATMENT WAS REQUIRED. WHEN REVIEWING REPORTABLE EVENTS FOR MALIBU BATHS, WE HAVE FOUND NO OTHER SIMILAR CASE WHEN THE RESIDENT'S SKIN WAS TRAPPED BETWEEN THE SEAT MOULDING AND THE SEAT FRAME, THEREFORE ISSUE VOICED BY THE CUSTOMER IN THIS CASE APPEARS TO BE AN ISOLATED OCCURRENCE. THE DEVICE WHICH WAS USED AT THE TIME OF THE EVENT WAS IDENTIFIED AS MALIBU BATH, MODEL NUMBER AZR23110-GB AND SERIAL NUMBER (B)(4). THE DEVICE WAS MANUFACTURED IN JANUARY 2013 AND AT THE TIME OF EVENT IT WAS FOUR YEARS OLD. MALIBU IS A FLEXIBLE SYSTEM INTENDED FOR THERAPEUTIC BATHING AND SHOWERING OF ADULT RESIDENTS UNDER THE SUPERVISION OF TRAINED CAREGIVERS WITH ADEQUATE KNOWLEDGE OF THE CARE ENVIRONMENT, ITS COMMON PRACTICES AND PROCEDURES, AND IN ACCORDANCE WITH THE GUIDELINES IN THE INSTRUCTIONS FOR USE (IFU). THE SEAT OF THE BATH WAS DESIGNED TO ALLOW TRANSFER WITHOUT NEED OF MANUAL LIFTING. THE RESIDENT IS SAT OUTSIDE THE BATH, THEN FULL SEQUENCE OF MOVEMENT IS PERFORMED: UP - OVER THE BATH TUB EDGE - AND DOWN INTO THE BATH TUB. DURING THE BATHING SESSION, THE RESIDENT SHALL STAY SEATED IN AN UPRIGHT POSITION, WHILE THE INDEPENDENT ACTUATORS OF THE SEAT AND THE BATH ALLOW FOR SUCH POSITIONING TO MAKE EASY ACCESS FOR CLEANING PARTS OF THE RESIDENT'S BODY. PRODUCT INSTRUCTIONS FOR USE (IFU, DOCUMENT NUMBER 04.AZ.00_8GB DATED ON JUNE 2012), WHICH IS DELIVERED WITH EVERY DEVICE, PRESENTS SAFETY GUIDELINES TO AVOID OF THE PATIENT FALLING: "WARNING! TO AVOID FALLING, MAKE SURE THE RESIDENT ALWAYS REMAINS IN A SEATED POSITION." "WARNING! TO AVOID FALLING, MAKE SURE THAT THE RESIDENT IS POSITIONED CORRECTLY AND THAT THE SAFETY BELT IS BEING USED, PROPERLY FASTENED AND TIGHTENED." DESPITE FACT THAT THE RESIDENT DID NOT FELL, IT WAS INDICATED THAT THE INCIDENT TOOK PLACE WHILE HE WAS STANDING UP DURING BATHING SESSION. THIS ACTION IS DEEMED AGAINST THE IFU AND COULD BE AN IMPORTANT FACTOR OF THE SEAT MOULDING INSTABILITY AND SKIN PINCHING. THE OTHER FACTOR INFLUENCING THIS INCIDENT WAS PLASTIC PART OF THE SEAT, WHICH ACCORDING TO ARJOHUNTLEIGH REPRESENTATIVE COULD BE LIFTED IN THE FRONT EDGE OF THE SEAT, MAKING A GAP. THIS PLASTIC PART IS DETACHABLE AND SHOULD BE REMOVED AFTER EVERY USE OF THE BATH FOR DISINFECTION. INSTRUCTION SUPPORTED BY THE PICTURES CAN BE FOUND IN THE PRODUCT IFU: "REMOVE [THE SEAT]: 1 WITH BOTH HANDS DETACH THE SEAT ON EACH SIDE AROUND THE ARM REST. 2 REPEAT ON THE OTHER SIDE. 3 PULL THE BOTTOM OF THE SEAT STRAIGHT UP." THE BATH TUB IN QUESTION WAS 4 YEARS OLD AND WAS SUBJECTED TO WEAR. AFTER MANY CYCLES OF DETACHING AND ATTACHING THE PLASTIC SEAT, THE STRUCTURE OF THE MATERIAL CAN CHANGE AND THE SHELL MIGHT BECOME EASIER TO DETACH. ARJOHUNTLEIGH REPRESENTATIVE, WHO PERFORMED THE DEVICE EVALUATION AFTER INCIDENT, STATED THAT THE SHELL IS IN GOOD CONDITION, WITH NO VISIBLE DAMAGE, BUT POSSIBLY LIFTING OFF THE SEAT FRAME IS A LITTLE EASIER THAN NORMAL. IN THE "CARE AND PREVENTIVE MAINTENANCE" SECTION OF THE IFU, THE CAREGIVER IS OBLIGATED TO VISUALLY CHECK ALL EXPOSED PARTS AS WELL AS MECHANICAL ATTACHMENTS EVERY WEEK, THEREFORE ANY LOOSE OF THE SEAT SHELL SHOULD BE DETECTED BEFORE USE AND THE PLASTIC PART SHOULD BE REPLACED. FROM THE INFORMATION COLLECTED TO DATE, WE CAME TO A CONCLUSION THAT THE MOST LIKELY CAUSE OF THE INCIDENT WAS LACK OF A PROPER CAREFULNESS WHEN INSPECTING THE DEVICE PRIOR TO USE. ADDITIONAL FACTOR MIGHT BE BEHAVIOR OF THE RESIDENT, WHO SHALL STAY SEATED DURING BATHING SESSION. IT SEEMS THAT THE FAILURE TO FOLLOW SAFETY INSTRUCTIONS AND RECOMMENDATIONS INCLUDED IN THE DEVICE INSTRUCTIONS FOR USE WAS A PRIMARY CAUSE OF THE EVENT OCCURRENCE. IF THAT ELEMENT OF USE ERROR WAS NOT IN PLACE, THE EVENT COULD PROBABLY HAVE BEEN PREVENTED. IN SUMMARY, THE DEVICE WAS NOT UP TO MANUFACTURER'S SPECIFICATION DURING THE EVENT OCCURRENCE - THE PLASTIC SEAT SHELL WAS FOUND TO BE POSSIBLE TO LIFT FROM THE SEAT FRAME. THE BATH TUB WAS USED FOR PATIENT HYGIENE AND IN THAT WAY IT PLAYED A ROLE IN THIS EVENT.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB LTD (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE 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 UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

Description of Event or Problem

ARJOHUNTLEIGH WAS INFORMED ABOUT AN INCIDENT ON MALIBU BATH. IT WAS REPORTED THAT DURING A BATHING SESSION, THE RESIDENT WAS STANDING UP WHEN HIS SCROTUM WAS NIPPED BETWEEN THE SEAT MOULDING AND THE SEAT FRAME CAUSING A SMALL CUT TO THE SKIN. THE CUT WAS CHECKED AND CLEANED, NO FURTHER TREATMENT WAS REQUIRED.