SENSATEC
Received Feb 1, 2006 · Event occurred Dec 31, 2005
Report 2134311-2006-00002 · MDR key 672276
Device
Generic name
Bed-chair Monitor
Manufacturer
R.f. Technologies, Inc.Model number
ST-320Catalog number
*
Lot number
UNK
Product problems
- Device Alarm System
Patient
79 YR
- Cyanosis
- Fall
- Hypoxia
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
THAT PATIENT WAS USING A CONTROLLER AND PAD. UNIT WAS ROUTINELY TESTED BY STAFF BEFORE PATIENT USE. PATIENT TRIED TO GET UP AND FELL. REPORT ALLEGED ALARM DID NOT SOUND. PATIENT HAD BEEN CALLING NURSES EVERY 3-4 MINUTES SO WHEN THEY HADN'T HEARD FROM HIM IN 11 MINUTES, THEY WENT TO CHECK AND FOUND HIM ON THE FLOOR. PATIENT WAS HYPOXIC (HE MIGHT HAVE BEEN THIS WAY BEFORE THE FALL) UNRESPONSIVE AND CYANOTIC. HE WAS TAKEN TO THE ER, BUT REGAINED CONSCIOUSNESS ON THE WAY THERE. FACILITY REPORTS HIS TRACH HAD BEEN DISPLAYED AND HIS G-TUBE HAD CAUSED SOME TRAUMA TO THE ABDOMINAL WALL. ACCORDING TO THE FACILITY THESE PROBLEMS WERE RESOLVED BY THE NEXT DAY.
Remedial action
- Relabeling