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	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation found that an echo cart was taking forty plus measurements for strain, the measurement for strain (gls, 2d) was not populating with the desired value.Support found the correct value that the customer wanted mapped.Support unmapped the string that was crossing into the report and mapped the desired string that the customer was looking for.The customer also requested that the value be rounded to the tenth decimal place and also not be shown as an absolute value.Support configured the string to populate to the tenth decimal place and without absolute value as requested.The site did not verify mapping before go live.After they went live they noticed it.This issue was resolved by support and loaded to their test system for validation.The correct strain measurement has been uploaded to production and this issue was resolved.The customer confirmed that no patients were harmed due to this issue.This was noticed right away after go live and the site had a work around in place while this was being corrected by support.Customer confirmed that this issue has been resolved.
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 the measurement for strain is not correct (gls, 2d).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).

• 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: 9681178
• Report Number: 2183926-2020-00003
• Device Sequence Number: 3414860
• Product Code: LLZ
• UDI-Device Identifier: 00842000100751
• UDI-Public: 00842000100751
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 01/15/2020

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 V11.1.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1