inforMED
OtherKMI

SENSATEC

Received Feb 1, 2006 · Event occurred Dec 31, 2005

Report 2134311-2006-00002 · MDR key 672276

Device

Generic name

Bed-chair Monitor

Model number

ST-320

Catalog 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