SKYTRON
Received Sep 20, 2007 · Event occurred Aug 28, 2007
Report 1825014-2007-00013 · MDR key 921716
Device
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