MalfunctionLMD
ARTIS ZEE FLOOR MN
Received Sep 24, 2012 · Event occurred Sep 17, 2012
Report 2770156 · MDR key 2770156
Device
Generic name
X-ray System, Cath/angio, With Magnetic Navigation
Manufacturer
Siemens Medical Solutions Usa, Inc.Model number
10094142Catalog number
*
Lot number
*
Product problems
- Device Operates Differently Than Expected
Patient
51 YR
- No Information
Narrative
Description of Event or Problem
X-RAY IMAGING SYSTEM HAD FAILED AND A VIDEO PC BOARD WAS RE-SEATED ON THE IAS PC. SYSTEM WAS STRESSED MULTIPLE TIMES WITH NO ISSUES.FIVE DAYS LATER, AFTER A PATIENT WAS SEDATED, THE SYSTEM WAS TESTED PRIOR TO THE PROCEDURE AND THE FLUOROSCOPY FUNCTION WAS NOT AVAILABLE. SYSTEM WAS REBOOTED FOUR TIMES WITH NO SUCCESS. THE PROCEDURE WAS CANCELLED. THE REPLACEMENT PC ARRIVED LATER THAT SAME DAY AND WAS REPLACED. SYSTEM IS NOW FULLY OPERATIONAL AFTER A WEEK OF OBSERVATION.