GUARDIAN
Received Feb 8, 2010 · Event occurred Jul 7, 2008
Report 1064427-2009-00027 · MDR key 1610470
Device
Product problems
- Computer Operating System Problem
- Connection Problem
Patient
UNK
- No Information
Narrative
Additional Manufacturer Narrative
THERE WAS NO PATIENT INVOLVED, THUS NO PATIENT DATA EXISTS. THE IBM SERVER IS THE DEVICE WHICH MALFUNCTIONED, HOWEVER, THE SERVER IS AN ACCESSORY TO THE OFFICEPACS SYSTEM. THEREFORE, THE INITIAL REPORTER WAS A SALES REPRESENTATIVE. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. EVALUATION SUMMARY - THE SYSTEM WAS EVALUATED REMOTELY ON 07/07/2008 AND IT WAS FOUND THAT THE GUARDIAN BACKUPS WERE FAILING. THE SITE WAS UNABLE TO CONNECT TO THE SERVER AND THEY WERE HAVING PROBLEMS REBOOTING. THERE IS A POTENTIAL FOR PATIENT DATA LOSS WHEN THE SERVER CRASHES. HOWEVER, THERE IS NO EVIDENCE OF ANY PATIENT DATA LOST FOR THIS MALFUNCTION. (B)(4).
Description of Event or Problem
THE SITE'S GUARDIAN BACKUPS ARE FAILING AND THE SERVER IS OFFLINE IN LOGMEIN. THE SITE IS UNABLE TO CONNECT TO THE SERVER.
Remedial action
- Recall