RIFTON DYNAMIC STANDER

Description of Event or Problem

WE UNDERSTAND THAT A STRUCTURAL COMPONENT OF THE STANDER FAILED, ALLOWING THE BODY SUPPORT MECHANISM TO SEPARATE FROM THE FRAME OF THE STANDER. THIS APPARENTLY CAUSED THE USER OF THE DEVICE TO FALL AND SUSTAIN A SLIGHT FRACTURE OF HER LEFT ARM.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION IS NEARLY 13 YEARS OLD AND HAD CHANGED HANDS AT LEAST ONCE. IT APPEARS TO HAVE BEEN POORLY MAINTAINED AND IN BAD REPAIR PRIOR TO THE INCIDENT. PRELIMINARY ANALYSIS SUGGESTS THAT THERE WOULD LIKELY HAVE BEEN VISIBLE CRACKING OF THE PART WELL BEFORE THE ALLEGED FAILURE THAT RESULTED IN THIS INCIDENT. SUCH CRACKING WOULD BE OBVIOUS TO A USER COMPLYING WITH THE INSTRUCTION IN THE DEVICE MANUAL TO PERIODICALLY INSPECT THE DEVICE FOR CRACKS. IT IS POSSIBLE THAT THE DEVICE WAS USED TO A MANNER FOR WHICH IT WAS NOT INTENDED. THE PRODUCT MANUAL INSTRUCTIONS SAY: "PERIODICALLY INSPECT FOR CRACKS, BREAKS, LOOSE OR MISSING PARTS, AND/OR MALFUNCTIONS. REMOVE THE PRODUCT FROM SERVICE WHEN ANY CONDITION DEVELOPS THAT MIGHT MAKE OPERATION UNSAFE."