inforMED
MalfunctionNVV

SUNQUEST POWERPATH

Received Aug 29, 2014 · Event occurred Jul 23, 2014

Report 2029302-2014-00004 · MDR key 4070910

Device

Generic name

Powerpath

Product 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