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

Model Number	10.3.1
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from merge healthcare and other vendors systems 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.Merge cardio is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician generated clinical reports (via structure reporting and template based tools), and to store this information in a database.On (b)(6) 2020, a customer contacted merge healthcare and stated that the mitral valve peak e velocity was displaying incorrectly on the cardio clinical report.Upon further investigation, measurement mapping strings were analyzed by merge healthcare support and it was determined that the e/e' average was being mapped to the mitral valve peak e velocity field.This mapping string was removed the issue was confirmed to be resolved.No further action is required.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).

• Brand Name: MERGE CARDIO
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• MDR Report Key: 11066481
• Report Number: 2183926-2020-00053
• Device Sequence Number: 4241827
• Product Code: LLZ
• UDI-Device Identifier: 00842000100041
• UDI-Public: (01)00842000100041(10)10312135(11)171024
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: 10.3.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/23/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1