HOYER LIFT W/SCALE

Additional Manufacturer Narrative

INVESTIGATION: TELEPHONE CONFERENCES WERE INITIATED BETWEEN (B)(6) AND SR INSTRUMENTS. TESTING INITIATED TRYING TO REPRODUCE THE MODE OF FAILURE, TO DETERMINE IF THE DEVICE WAS USED PROPERLY OR AS INTENDED. SR INSTRUMENTS DOING MATERIAL TESTING, VERIFIED STEELS HEAT TREATING PROCESSES AND VERIFIED MATERIAL TYPE. (B)(4) PERFORMING SAFETY PERFORMANCE TESTING.

Description of Event or Problem

IT WAS REPORTED TO MANUFACTURING BY THE DISTRIBUTOR VIA THE FACILITY. PER THE FACILITY CALLED STATING THAT DURING A PT TRANSFER THE LIFT BROKE, THE BOLT/PIN COMING UP THROUGH THE CRADLE TO THE SCALE BROKE, CAUSING THE ASSEMBLY TO TILT AND THEN A DOG EAR PIECE BROKE OFF RESULTING IN THIS FALL. THE RESIDENT FELL BACK ONTO THE BED WITH THE CRADLE LANDING ON TOP OF HER, NO APPARENT INJURY, FACILITY STILL ACCESSING THE INCIDENT. AN RA WAS ISSUED BY THE DISTRIBUTOR TO GET THE SCALE AND CRADLE RETURNED FOR EVALUATION. SAID EVALUATION WAS RECEIVED FROM THE DISTRIBUTOR.