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

Model Number	10.3.1(01) 00842000100041 (10) 10312135 (11) 171024
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	10/22/2020
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 three measurements were mapped incorrectly (mean velocity ratio, aortic valve area mean velocity, and aortic valve area bsa mean velocity).Merge healthcare is currently working with the customer to resolve this issue with the customer.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).
Additional 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 10/22/2020.After investigation by merge healthcare support and the customer, the measurements were remapped and confirmed to be displaying correctly on the clinical cardio report.No further action is required.Revised information contained in this supplemental report includes the following: g6 - indication that this is follow-up report 001.H6 - evaluation codes:investigation conclusions: 143 quality control deficiency.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.

• Brand Name: MERGE CARDIO
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• MDR Report Key: 10721794
• Report Number: 2183926-2020-00045
• Device Sequence Number: 3060351
• Product Code: LLZ
• UDI-Device Identifier: 00842000100041
• UDI-Public: (01)00842000100041(10)10312135(11)171024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 10/22/2020

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(01) 00842000100041 (10) 10312135 (11) 171024
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 02/03/2021
• 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