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

Model Number	MERGE CARDIO V10.3.1
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer contacted merge stating that there were issues with measurement mapping of ejection fraction, tr values and av peak vs mean values.At this time merge support is still working with the customer to correct the measurement mappings.When more information becomes available a supplemental with be submitted.
Event or Problem Description
Indications for use: 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.Merge cardio is software comprised of modules that perform under standard "off the shelf" personal computers and servers running the microsoft windows 2000/2003/xp operating systems.Merge cardio is image data storage and display software that accepts dicom (digital imaging and communications in medicine) image data files from multiple modalities.It accepts text data using other standards-based formats including but not limited to hl7 and xml.Merge cardio is an internet/intranet network system that is designed for small and large, multi-user environments.The merge cardio network structure (including server and workstations) provides for the system's database management, storage, printing, and all dicom/hl-7 interface services.On (b)(6) 2020, a customer contacted merge healthcare and stated that multiple diagnostic measurements were populating the clinical report incorrectly.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.Reference case (b)(4), 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 (b)(6) 2020.Initial submission included that there were issues with measurement mapping of ejection fraction, tr values and av peak vs mean values.Support and the customer investigated the issues of incorrect measurements mapping to the clinical report.The customer was expecting a different ef value to be populating the ef field.Support found several ef measurements taken, located the string that the customer was expecting to map, unmapped the current string and mapped the expected string to resolve the ef mapping issue.The customer and modality vendor was able to resolve the issue of the tr values and av peak vs means values internally.Support also mapped several mr and strain measurements as requested by the customer to resolve the issue 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: g4 - date new information received by manufacturer.G7 - 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: method code: 10 - testing of actual/suspected device.Results code: 3208 - configuration issue.Conclusions code: 21 - caused traced to infrastructure.H10 - indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE CARDIO
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, wi
• MDR Report Key: 9786047
• Report Number: 2183926-2020-00006
• Device Sequence Number: 2289066
• Product Code: LLZ
• UDI-Device Identifier: 00842000100041
• UDI-Public: 00842000100041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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 V10.3.1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1