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

Model Number MERGE CARDIO V10.3

Device Problem Data Problem (3196)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currenly under investigation by merge healthcare.For this reason, conclusions code 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) 2018, a customer contacted merge healthcare and stated that measurement calculations are not appearing properly in the diagnostic report.Due to an incorrect values displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in harm.(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 03/27/18.The customer stated that the pasp measurement was calculating incorrectly on the clinical report.The customer was expecting the pasp measurement to equal the rvsp measurement.After investigation conducted by merge support it was found that pasp will equal rvsp in the absence of a gradient across the pulmonic valve.This expectation (the conditions under which pasp will not equal rvsp) and the equations (simplified bernoulli equation) can be found in the current ase guidelines and standards for the echocardiographic assessment of the right heart in adults.This was verified with engineering, reporting, and solutions management that current pasp calculation in clinical reporting is correct.No further action is required.This information was relayed to the customer.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 device was evaluated by manufacturer.

• 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: 7373364
• MDR Text Key: 103698780
• Report Number: 2183926-2018-00020
• 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: 03/01/2018

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 V10.3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1