FREEDOM BATH

Description of Event or Problem

(B)(4).

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJO (B)(4) ON BEHALF OF THE IMPORTER (B)(4). PLEASE NOTE THAT THE INCIDENT WAS ON (B)96) 2013 THE MFR REC'D ADD'L INFO FROM THE COMPANY REP WHICH MADE THIS INCIDENT REPORTABLE, IN ABUNDANCE OF CAUTION, DUE TO POTENTIAL FOR PT INJURY IF IT WILL RECUR. WHEN REVIEWING SIMILAR REPORTED EVENTS, NO OTHER CASES WITH SIMILAR FAULT DESCRIPTION (BATH NOT ANCHORED TO THE FLOOR) WERE FOUND. (B)(4). WE WERE ABLE TO FIND A DEFICIENCY WITH THE DEVICE, IT WAS NOT CORRECTLY INSTALLED (ANCHORED) TO THE FLOOR. THIS MEANS THAT THE FREEDOM BATH DEVICE WAS NOT UP TO SPECIFICATION WHEN THE INCIDENT TOOK PLACE. THE DEVICE WAS NOT BEING USED FOR PT HANDLING AT THE TIME OF INCIDENT. FROM OUR EVALUATION IT APPEARS A NUMBER OF USE ERRORS CAUSED THE EVENT. THE MOST RELEVANT USE ERROR RELATED WITH THE FAILURE IN BATH INSTALLATION TO THE FLOOR: IT IS STATED IN THE ASSEMBLY AND INSTALLATION INSTRUCTION (06.AF.02/4GB - DATED MAY 2007). 'THE SLIDING RAILS PROVIDED IN THE INSTALLATION KIT HAS TO BE USED WHEN INSTALLING THE FREEDOM BATH. THE FLOOR CONSTRUCTION MUST BE SUITABLE FOR ANCHORING THE BOLTS'. 'MAKE SURE THAT THE ANCHORS ARE FULLY INSERTED INTO THE FLOOR AND THAT THEY ARE NOT PROTRUDING.' WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MFG ANOMALIES. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A MAINTENANCE AND INSTALLATION ERROR AS THE REC'D INFO AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE INSTRUCTION FOR USE SAFETY WARNING ARE FOLLOWED THERE WILL BE NO PT OR CAREGIVER RISK.