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SKYTRON

Received Sep 20, 2007 · Event occurred Aug 28, 2007

Report 1825014-2007-00013 · MDR key 921716

Device

Generic name

Surgical Table

Model number

6500NB

Product problems

  • Self-Activation or Keying
  • Table, tilting

Patient

YR

  • Injury

Narrative

Additional Manufacturer Narrative

SKYTRON WAS MADE AWARE OF THIS INCIDENT IN 2007, HOWEVER, WE WERE TOLD BY THE HOSPITAL'S BIO-TECHNICIAN THAT THERE WERE NO INJURIES. WE CONTACTED OUR DISTRIBUTOR IN THE AREA, AND ASSOCIATES TO GO TO THE HOSPITAL AND EXAMINE THE TABLE. THE HOSPITAL WAS ADVISED BY SKYTRON TO TAKE THE TABLE OUT OF SERVICE BUT THEY REFUSED. THEY MADE THE DECISION TO USE THE TABLE WITHOUT REPAIR REGARDLESS OF THE RISK. UNK SERIAL NUMBER AT THIS TIME. WE WERE INFORMED ON THE FOLLOWING MONTH, THAT THERE WAS AN INJURY TO A PATIENT AND ARE AWAITING THE INFORMATION. THE TABLE HAS BEEN REPAIRED AND CONTINUES TO BE IN SERVICE. WE WILL SEND A FOLLOW UP AS SOON AS THE DETAIL OF THE INJURY IS KNOWN.

Description of Event or Problem

HOSPITAL CLAIMS SKYTRON'S 6500 SURGICAL TABLE WENT INTO TRENDELENBURG AND TILT LEFT ON IT'S OWN. HOSPITAL NOW CLAIMS AN INJURY TO PATIENTS BOWEL.

Remedial action

  • Repair