MalfunctionLMD
EASYACCESS
Received Jun 22, 2006 · Event occurred May 21, 2006
Report 1217116-2006-00021 · MDR key 860936
Device
Generic name
Picture Archiving Communication System
Manufacturer
Philips Medical SystemsModel number
830018Catalog number
NA
Lot number
NA
Product problems
- Failure to Back-Up
- Computer Software Problem
- Replace
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
CONCLUSION: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem
THIS RADIOGRAPHIC DATABASE SYSTEM WAS UPDATED TO THE NEWEST RELEASED SOFTWARE. AFTER THE UPGRADE, THE SYSTEM COULD NO LONGER RETRIEVE THE OLD PT IMAGE INFO. THE HOSPITAL BELIEVES THIS IS A POSSIBLE SAFETY ISSUE NOT BE ABLE TO RETRIEVE OLD IMAGES. THERE WERE NO INJURIES TO PTS. NEW SOFTWARE HAS BEEN INSTALLED TO CORRECT PROBLEM.