GUARDIAN
Received Feb 8, 2010 · Event occurred Aug 19, 2008
Report 1064427-2009-00036 · MDR key 1609566
Device
Product problems
- Computer Operating System Problem
Patient
UNK
- No Information
Narrative
Additional Manufacturer Narrative
THERE WAS NO PATIENT INVOLVED, THUS NO PATIENT DATA EXISTS. THE INITIAL REPORTER WAS AN IT ENGINEER. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THIS IS A REMOTE DATA BACKUP SERVICE OF WHICH THERE IS NO OPERATOR. ACTUAL DEVICE WAS EVALUATED REMOTELY. THERE IS NO KNOWN INFORMATION ON THE MANUFACTURE DATE AT THIS TIME. EVAL SUMMARY - THE SYSTEM WAS EVALUATED REMOTELY ON 08/19/2008 AND FOUND TO HAVE TOO MANY FILES FOR GUARDIAN TO SUPPORT. WHEN THERE ARE TOO MANY FILES PRESENT, GUARDIAN CANNOT PERFORM BACKUPS DURING THE HOURS ALLOTTED TO THIS TASK SO, IT WILL CONTINUE TO RUN THROUGH BUSINESS HOURS THUS SLOWING DOWN THE SITE'S SYSTEM. AT THIS POINT GUARDIAN IS SHUT DOWN WHICH CREATES A POTENTIAL FOR PATIENT DATA LOSS. HOWEVER, THERE IS NO EVIDENCE OF ANY PATIENT DATA LOSS IN THIS PARTICULAR INSTANCE. THIS IS NOT A SINGLE USE DEVICE. (B)(4)
Description of Event or Problem
THE GUARDIAN REPLIWEB UNABLE TO HANDLE THE SITE FILES.
Remedial action
- Recall