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

Model Number MERGE CARDIO V10.1.2

Device Problem Data Problem (3196)

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

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currently under investigation by merge healthcare.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) 2017, a customer contacted merge healthcare and stated that diagnostic measurements taken by their modality needed to be corrected.Due to an incorrect value displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in 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 07/14/2017.The customer stated that the mitral valve peak e velocity measurement coming from one ultrasound cart was incorrect.It was found that the mitral valve peak e velocity measurement was being mapped with three different report strings, once the two incorrect mapping string were removed, the measurement consistently mapped correctly.Two additional measurements were requested to be mapped but due to software limitations, the additional requested measurements could not be mapped, but can be manually entered into the clinical report.No further action is required.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.Revised information contained in this supplemental report includes the following: date new information received by manufacturer.Indication that this is follow-up report 001.Indication of malfunction as reportable event.Indication of additional information.Indication evaluated by manufacturer.Evaluation codes: methods code: 10 - testing of actual/suspected device.Results code: 3208 - configuration issue.Conclusions code: 21- cause traced to infrastructure.Indication of additional manufacturer information is contained in this follow-up report.

• 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: 6716417
• MDR Text Key: 80283397
• Report Number: 2183926-2017-00149
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1