HANDICARE

Additional Manufacturer Narrative

INFORMATION PREVIOUSLY PROVIDED BY FACILITY INDICATED THEY ARE USING AN UNAPPROVED WASH PROCESS AND NOT RETIRINING SLINGS ACCORDING TO OUR INSTRUCTIONS FOR USE. FACILITY WAS PREVIOUSLY NOTIFIED THAT WE PERFORMED TESTING THAT INDICATED THAT THEIR WASH PROCESS IS DEGRADING THE INTEGRITY OF THE SLING THREAD AND WAS INSTRUCTED TO CHANGE THEIR PROCESS TO BE IN LINE WITH OUR INSTRUCTIONS FOR USE ON LAUNDERING. THEY WERE ALSO INSTRUCTED TO FOLLOW GUIDELINES IN THE IFU REGARDING WHEN SLINGS SHOULD BE RETIRED DUE TO SIGNS OF DEGREDATION. INSTRUCTIONS FOR USE THAT INCLUDE OUR APPROVED LAUNDRY PROCESS AND INSTRUCTIONS FOR INSPECTING AND RETIRING SLINGS ARE PROVIDED IN THE PACKAGING OF EACH SLING. FOLLOWING THIS INCIDENT, THE FACILITY CONFIRMED THAT THEY HAVE CONTINUED TO USE THE UNAPPROVED WASH PROCESS AND CONTINUED TO USE SLINGS THAT ARE SHOWING SIGNS OF DEGREDATION THAT OUR IFU INDICATES SHOULD BE RETIRED. THE FACILITY HAS ACKNOWLEDGED THE PROPER TREATMENT OF THIS SLING FAMILY IN WRITING BUT HAS NOT FOLLOWED THE INSTRUCTIONS.

Description of Event or Problem

CAREGIVER WAS USING THE SLING TO TRANSFER THE PATIENT TO A CHAIR. AS THEY WERE LOWERING THE PATIENT, THE THREAD ON THE BAR TACKS CONNECTING TWO OF THE SIDE HANDLES TO THE SLING BROKE APART, CAUSING THE TWO HANDLES TO DETACH FROM THE SLING. THE PATIENT WAS CLOSE TO THE CHAIR AND THEY WERE ABLE TO GET HIM INTO THE CHAIR WITH NO INJURIES.