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

Model Number	MERGE CARDIO V11.1.1
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer confirmed that no patient harm was caused due to this issue.This is happening with all us carts since the upgrade and the issue is readily apparent to the techs and physicians at this time merge support is working with the customer to correct the measurement mapping configurations for the customer.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 12/30/2019, a customer contacted merge healthcare and stated that after upgrade, 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 01/24/2020.Initial submission included that after an upgrade, several measurements were incorrect or missing.Support and the customer investigated together incorrect measurements populating the report post upgrade.The lv mmode measurements were populating the lv 3d fields.Support corrected the mapping strings so that lvmmode measurements populate the lv mmode fields, at this time lv3d measurements are unable to be mapped and will have to be manually entered.The lvot measurement was populating both the lvot field and tr vena contracta field, support removed the duplicate mapping string from the tr vena contracta field.Ivs ed lax was populating both ivs ed lax and the ivc field.It was determined that ivc was correct and the ivs ed lax was the duplicate and support removed the duplicate mapping string.Support also mapped several other measurements that were not mapped.The issue of incorrect measurements on the clinical report has been resolved.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.

• 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 53029
• MDR Report Key: 9628032
• Report Number: 2183926-2020-00002
• Device Sequence Number: 2884547
• Product Code: LLZ
• UDI-Device Identifier: 00842000100751
• UDI-Public: 00842000100751
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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 V11.1.1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 01/24/2020
• 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