RAYE'S, INC DBA SIZEWISE MANUFACTURING

Additional Manufacturer Narrative

DEVICE MISUSE: BEDFRAME USED IN HOME (VS HEALTHCARE) SETTING. USER SAT AT HEAD END OF BED WHILE HOLDING HEADBOARD AND UTILIZED THE BED HEAD-END RAISE FUNCTION VIA HAND CONTROLLER TO LIFT ENTIRE BODY WEIGHT TO ASSIST WITH STANDING. THE IMPROPER WEIGHT DISTRIBUTION RESULTED IN ACTUATOR FAILURE.

Description of Event or Problem

BEDFRAME NOT WORKING PROPERLY WHILE IN PATIENT USE, HOWEVER PATIENT WAS NOT INJURED. BED'S HEAD ARTICULATION HAS MOVEMENT BUT IS JERKY. PATIENT NEEDS TO HELP THE ACTUATOR IN ORDER FOR IT TO MOVE. ACTUATOR GIVES OUT WHEN PUTTING A LOAD OF WEIGHT ON IT.