InjuryKMI
SENSATEC
Received Dec 29, 2004 · Event occurred Nov 24, 2004
Report 2134311-2004-00001 · MDR key 562632
Device
Generic name
Bed-chair Monitor
Manufacturer
R.f. Technologies, Inc.Model number
ST-260Catalog number
1000-0875
Lot number
*
Product problems
- Alarm, failure of warning
- Use of Device Problem
Patient
*
- Fall
- Hip Fracture
- Hospitalization required
Narrative
Description of Event or Problem
PATIENT WAS USING CONTROLLER WITH A BED PAD. WHEN PT TRIED TO GET UP, PT FELL. THE REPORT ALLEGED THAT THE ALARM DID NOT SOUND. REPORT ALSO INDICATED THAT THE PT BROKE THEIR HIP. COMPLAINANT BELIEVED THAT THE PAD WAS IN USE BEYOND THE LABELED 30-DAY USE PERIOD.
Remedial action
- Replace