WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT THE DIAGNOSTIC CARDIOLOGY SUITE HAD INCORRECT PATIENT INFORMATION PULLED IN WHEN TAKING EXAM THROUGH VERADIGM/ALLSCRIPTS. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.