ENDOWORKS
Received May 19, 2009 · Event occurred Apr 3, 2009
Report 3006219967-2009-00001 · MDR key 1461111
Device
Generic name
Uninterruptable Power Supply, Endoworks
Manufacturer
Olympus America, Inc.Model number
IBM 2130TU1Catalog number
52026
Product problems
- Loss of Power
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS ONSITE AT THE TIME OF THE EVENT AND WAS NOTIFIED OF THE EVENT. THE FSE NOTICED SMELL OF SMOKE COMING FROM THE UPS DEVICE BUT SAW NO PHYSICAL SIGNS OF DAMAGE. THE FSE NOTED THAT THE ONLY DEVICE ATTACHED TO THIS UPS WAS THE ENDOWORKS COMPUTER. ALL OTHER DEVICES (MONITOR, VIDEO PROCESSOR., LIGHT SOURCE, ETC) WERE ALL POWERED BY THE TRANSFORMER ON THE ENDOSCOPY CART. THE FSE RE-APPLIED POWER TO THE ENDOSCOPY CART, TURNED ON ALL EQUIPMENT ON THE ENDOSCOPY CART, AND OBSERVED NO MALFUNCTIONS OF ANY DEVICE NOR ANY SMOKE COMING FROM THE UPS DEVICE. THE FSE WAS ASKED TO REMOVE THE UPS FROM THE ENDOSCOPY CART. THE UPS WAS RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE UPS WAS MALFUNCTIONING. THE CAUSE OF THE FAILURE COULD NOT BE DETERMINED. THE UPS WAS REPLACED.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT PRIOR TO AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE ENDOSCOPY EQUIPMENT ON A ENDOSCOPY CART SUDDENLY POWERED OFF AND SOME LIGHTS WERE OBSERVED FLASHING. THEREAFTER, SMOKE WAS OBSERVED COMING FROM THE UNINTERRUPTIBLE POWER SUPPLY (UPS) USED IN THE ENDOSCOPY CART. THE USERS REMOVED THE EQUIPMENT FROM THE ROOM FOR RISK OF FIRE IN AN OXYGEN RICH ENVIRONMENT. THE CART WAS UNPLUGGED AND REMOVED FROM THE ROOM. A SECONDARY CART WAS BROUGHT IN FOR THE PROCEDURE. THE SECONDARY CART WAS USED WITHOUT ANY FURTHER ISSUES. THIS CASE STUDY WAS COMPLETED.
Remedial action
- Replace