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

Model Number MERGE CARDIO V10.1.2

Device Problem Patient Data Problem (3197)

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

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currently under investigation by merge healthcare.For this reason, conclusions code (conclusion not yet available-evaluation in progress) was used.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 reported to merge healthcare that fetal measurements taken by their 3rd party modalities were populating the merge cardio clinical reporting fetal knowledgebase with incorrect z-score values.With merge cardio incorrectly populating z-score values that are used for diagnosis, there is a potential for incorrect treatment of a patient that could result in harm.At this time no information has been provided that indicates that a death or serious injury has occurred as a result of this issue.(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 20122016.An internal investigation was completed by merge healthcare (vrcs-13482) and it was found that this works as designed because this problem does not occur as a result of a software defect but because of an incorrect workflow that the customer has chosen to use.The wrong dicom sr template is being created by the siemens echo cart.Fetal echocardiography is routinely performed to screen for right or left ventricular hypoplasia, mitral stenosis, aortic stenosis, and pulmonary stenosis or atresia.Z-scores provide fetal cardiac dimensions- including the mitral valve, left ventricle, aortic valve, and ascending aorta.Support has provided guidance and a workaround to the user for fetal measurement entry.No further actions are anticipated at this time.Revised information contained in this supplemental report includes the following:.

• 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: 6192198
• MDR Text Key: 62919210
• Report Number: 2183926-2016-00822
• 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: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.1.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1