TRAPEZE FLOOR STAND - DEVICE #1

Description of Event or Problem

IT WAS REPORTED TO MFR, BY FACILITY AND REPORTER, PER FACILITY THEY HAVE A 325 LB MAN USING THE TRAPEZE FOR BED MOBILITY / REPOSITIONING AND NOT SUPPORTING HIS 325 LB WEIGHT. THE TRAPEZE TRIANGLE WAS ON THE FLOOR WHEN THEY FOUND IT, AND THE RESIDENT STATED THAT IT HIT HIM IN THE HEAD, RESIDENT DID HAVE A BUMP TO HIS HEAD. FACILITY ALSO SAID THE STATE WAS IN AND THEY DID A STATE INCIDENT REPORT ON THIS. PER MFR IN OUR USER INSTRUCTION MANUAL, IT STATES UNDER THE WARNINGS "THE HEAD TRAPEZE, USED IN CONJUNCTION WITH A BED, CAN SUPPORT AN INDIVIDUAL WEIGHING UP TO 250 LBS." FACILITY IS STATING BECAUSE WE DO NOT HAVE A LABEL ON THE TRIANGLE ITSELF AND BECAUSE WE STATE "CAN SUPPORT" AND "ASSISTS THE USER WHEN REPOSITIONING IN BED" FACILITY WANTS TO KNOW WHAT DO WE MEAN BY THAT VERBAGE. FACILITY INSISTS WE ARE NOT CLEAR, AND BECAUSE THE PT WAS USING IT FOR BED MOBILITY / REPOSITIONING AND NOT SUPPORTING HIS 325 LBS, THEY WANT SOMETHING IN WRITING FROM US. PER MFG THIS IS IN QUESTION; BECAUSE WE BELIEVE WHEN A PERSON IS REPOSITIONING OR USING A TRAPEZE FOR BED MOBILITY YOU ARE SUPPORTING/ UTILIZING YOUR WEIGHT. PER PRODUCT MANAGER, IF THE TRAPEZE IS PROPERLY INSTALLED AND THE TRIANGLE LOCKED DOWN, PER THE MFR INSTALLATION INSTRUCTIONS, THERE IS NO WAY FOR IT TO FALL OFF.