GUARDIAN
Received Feb 8, 2010 · Event occurred Jul 3, 2008
Report 1064427-2009-00025 · MDR key 1610463
Device
Product problems
- Failure to Back-Up
Patient
UNK
- No Information
Narrative
Description of Event or Problem
THE GUARDIAN REPLIWEB COULD NOT BACK THE SITE UP BECAUSE OF TOO MANY FILES.
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. EVALUATION SUMMARY - THE SYSTEM WAS EVALUATED REMOTELY ON 07/03/2008 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. (B)(4).
Remedial action
- Recall