HOYER LIFT W/SCALE
Received Jul 23, 2010 · Event occurred Apr 23, 2010
Report 1317256-2010-00002 · MDR key 1780899
Device
Generic name
Patient Lifter W/scale
Manufacturer
Sr Instruments, Inc. (scale Manufacturer Only)Model number
HPL700 W/SCALECatalog number
HPL700/WSC
Product problems
- Break
Patient
UNKNOWN
- Fall
- Injury
Narrative
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. USING THE REPLACEMENT PT LIFTER SENT, THE SAME AREA FAILED IE 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 PT FELL BACK ONTO THE BED, HOWEVER, THE PT WAS INJURED WHEN THE CRADLE LANDED ON TOP OF HER RESULTING IN THE INJURY, RA ISSUED FOR THE RETURN OF PARTS. THE DISTRIBUTOR ISSUED A CAPA (B)(4) TO THE MANUFACTURER.
Remedial action
- Inspection