MalfunctionNVV
SUNQUEST POWERPATH
Received Aug 29, 2014 · Event occurred Jul 23, 2014
Report 2029302-2014-00004 · MDR key 4070910
Device
Generic name
Powerpath
Manufacturer
Sunquest Info SystemsProduct problems
- Programming Issue
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
NINETY FIVE SITES HAVE BEEN NOTIFIED VIA PRODUCT SAFETY NOTICE (PSN) AND A CORRECTION WILL BE AVAILABLE AS AN EMERGENCY PATCH FOR ALL AFFECTED VERSIONS. THERE ARE 0 SITES THAT HAVE ALREADY BEEN CORRECTED. NO INSTANCES OF PT HARM HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE.
Description of Event or Problem
THIS ISSUE WAS FOUND BY A CLIENT AT SITE. IN POWERPATH, ON RARE INSTANCES, TWO REPORTS MAY BE CREATED FOR THE SAME CASE AT THE TIME OF CASE SIGN-OUT. THESE REPORTS MAY CONTAIN INCOMPLETE DIAGNOSTIC INFO AND MAY BE SENT OVER THE RESULTS INTERFACE OR DISTRIBUTION SERVICES.
Remedial action
- Modification/Adjustment