MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CARDIO; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS

Model Number MERGE CARDIO V10.1.1.1

Device Problem Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is working with the customer to resolve this issue.When more information becomes available, a supplemental report will be submitted.

Event Description

Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.On (b)(6) 2016, a customer contacted merge healthcare and stated that merge cardio's pdf reports were posting under the wrong patient in their hospital information system.Clinical reports posting under the wrong patient has potential for incorrect treatment of the patient which may lead to patient harm.The customer was contacted and stated that no patient harm was caused due to this issue and that it is readily apparent to the user.Reference complaint number (b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 11/19/2016.An internal investigation was completed by merge healthcare ((b)(4)) and it was found that, after a doctor confirms a report, it gets saved as a pdf and is given a numerical name in sequence.Periodically the report is being stored without that numerical name, just as ".Pdf".This causes issues with saving in the emr.Updating permissions on the get formatted file name sp in condor database will resolve this issue.The issue, which is readily apparent, does not pose patient safety concerns.The potential impact to a patient has been reviewed and the risk level has been assessed as low (non-serious injury).Additionally, a low number of customers have reported this issue therefore reducing the frequency of occurrence.No further actions are anticipated at this time due to the issue being readily apparent, the low number of complaints, the ability for merge support to correct this issue by updating the database and low impact on patients.Revised information contained in this supplemental report includes the following: g7 - indication that this is follow-up report 001.H6 - evaluation codes: methods code: 22 - software evaluation (blank in initial report).Results code: 3208- configurations issue.Conclusions code: 14 - device incorrectly prepared for use or modified.

• Brand Name: MERGE CARDIO
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 6115478
• MDR Text Key: 60436446
• Report Number: 2183926-2016-00795
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K051649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.1.1.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/19/2016
• Supplement Dates Manufacturer Received: 12/13/2016
• Supplement Dates FDA Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1