inforMED
MalfunctionFRI

MDR event

Received Sep 14, 2015 · Event occurred Feb 20, 2015

Report 3000122543-2015-00001 · MDR key 5098023

Device

Model number

H140-10-5

Product problems

  • Inappropriate/Inadequate Shock/Stimulation
  • Device Displays Incorrect Message

Patient

44 YR

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE SCALE COULD NOT BE EVALUATED. IT WAS NOT RETURNED. THE USER HAS BEEN CONTACTED REQUESTING ADDITIONAL INFO ON LOCATION OF SCALE. TO DATE SCALE HAS NOT BEEN LOCATED. THERE WAS NO REPORT OF INJURY. THE MALFUNCTION REPORTED WOULD NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

Description of Event or Problem

TITLE: XXXXX. EVENT DESC: PT WEIGHED BEFORE SURGERY. PT'S WOOL SWEATER TOUCHED THE METAL HEIGHT BAR. THE RICE LAKE STANDING SCALE MADE A LOUD SPARK AND HAD SOME WHITE SMOKE. THEN THE RICE LAKE STANDING SCALE TURNED OFF. WHEN THE NURSE TURNED IT BACK ON IT HAD LINES "SLOP". THE PT DID NOT SUSTAIN ANY INJURY. WHAT WAS ORIGINAL INTENDED PROCEDURE? WEIGH PT BEFORE SURGERY. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).