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

Model Number	MERGE CARDIO 11.1.1
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); Patient Data Problem (3197)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
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 stress data was labeled incorrectly.Merge healthcare support has been in contact with the customer multiple times since this report and is currently working on gathering further information.At this time, there are no reports of patient harm or injury due to this issue.A supplemental report will be submitted as soon as more information is available.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 8/28//2020.After additional troubleshooting by merge healthcare technical support, the measurements in question were re-mapped and tested and confirmed to be displaying correctly.The customer was repeatedly nonresponsive and needed many follow ups to confirm.No further action is required.Revised information contained in this supplemental report includes the following: g3 - date new information received by manufacturer.G6 - indication that this is follow-up report 001.H1 - indication of malfunction as reportable event.H2 - indication of additional information.H3 - indication that device evaluated by manufacturer.H6 - evaluation codes: health effect - clinical code: 4582 no clinical symptom/sign.Health effect - impact code: 2199 no health consequences or impact.Medical device problem code: 1449 application program problem: parameter calculation error.Component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 10 testing of actual/suspected device.Investigation findings: 3200 incorrect data definition.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: 10468855
• Report Number: 2183926-2020-00032
• Device Sequence Number: 16763172
• Product Code: LLZ
• UDI-Device Identifier: 00842000100751
• UDI-Public: 00842000100751
• Combination Product (Y/N): N
• 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): 08/28/2020

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: MERGE CARDIO 11.1.1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 08/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2019
• 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