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

Model Number MERGE CARDIO V9.0.8

Device Problem Data Problem (3196)

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

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is working to contact the patient to evaluate for patient safety issues due to this user error.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 they could not find a study.This study was completed under a different patient/order in error and then the physician reported on the images with the incorrect patient information and patient order.The clinical report was confirmed on the wrong patient with the wrong patient information, this has the potential for incorrect diagnosis or treatment of the patient which may lead to patient harm.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 08/22/2016.An internal investigation was completed by merge healthcare and it was found that, a report was made under the incorrect patient and sent to the emr.This was found to be a user error as the wrong patient/order was chosen from the modality worklist prior to imaging.The physician then completed a report on the images that belonged to a different patient as they were listed with the patient/order that was chosen from the modality worklist.Merge support worked with the customer to study edit and correct this.He sent a new study from their emr for this.Study edited, hid the original study, and assured order associated correctly.The issue, which is readily apparent, and appears that this issue did not cause patient harm due to several attempts to reach the customer and it was never reported by the customer according to the maude database.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 study edits and resending the corrected report 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: 213- no failure detected.Conclusions code: 61- use error caused or contributed to event.

• 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: 6095053
• MDR Text Key: 59755775
• Report Number: 2183926-2016-00790
• 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: 10/11/2016

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 V9.0.8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1