inforMED
MalfunctionBWN

AMSCO

Received Jun 20, 2013 · Event occurred May 21, 2013

Report 3250735 · MDR key 3250735

Device

Generic name

Table, Surgical

Manufacturer

Steris Corporation

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Failure to Power Up
  • Device Operates Differently Than Expected

Patient

61 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE OR TABLE WAS CHECKED AND WAS FUNCTIONAL PRIOR TO BEGINNING THE CASE. PATIENT MOVED ONTO THE OR TABLE AND, WHEN PATIENT WAS SECURED TO THE TABLE, IT WAS UNLOCKED AND THE TABLE WAS MOVED INTO SURGICAL POSITION. UPON ATTEMPTING TO LOCK THE TABLE AGAIN, THERE APPEARED TO BE NO ELECTRICITY TO THE BED TO LOCK IT. THE PLUG WAS REMOVED AND CHANGED OUT WITH ANOTHER PLUG, STILL COULDN'T LOCK THE BED. THE PLUG WAS THEN PLUGGED INTO DIFFERENT OUTLETS, WITHOUT SUCCESS. THE PATIENT HAD TO BE MOVED TO A DIFFERENT OR TABLE.======================MANUFACTURER RESPONSE FOR OPERATING ROOM SURGICAL TABLE, SURGICAL TABLE (PER SITE REPORTER).======================MANUFACTURER RESPONSE FOR SURGICAL TABLE, SURGICAL TABLE (PER SITE REPORTER).======================NONE AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SHOULDER ARTHROSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.