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

Model Number	12.1.1
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
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 02/24/2022, an internal clinical reporting specialist found an incorrectly mapped measurement during an upgrade to merge cardio version 12.1.1.The customer requested hepatic vein measurements to be configured on merge cardio reports.It was found that the hepatic vein diastolic peak velocity displays as mean velocity.Work is ongoing between the customer and merge healthcare clinical reporting engineering.A supplemental report will be filed when further information becomes available.This has the potential to delay patient treatment and/or diagnosis or may result in an incorrect diagnosis &/or treatment.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).
Additional Manufacturer Narrative
An investigation into the hepatic vein diastolic peak measurement versus the hepatic vein diastolic mean velocity measurement mis-mapping is ongoing.A supplemental report will be filed when additional information becomes available.
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 3/22/2022.After additional troubleshooting by merge healthcare technical support and cardio clinical report engineering, an incorrect mapping within the report measurement mapping tool (rmmt) was identified as the cause of the hepatic vein diastolic peak velocity appearing in the mean velocity measurement field.Settings within merge cardio were adjusted to ensure that the peak velocity appears in the correct field.The configuration setting adjustments were tested and confirmed to map correctly.This resolved the issue with the hepatic vein peak and mean velocity fields.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 - impact code 2645 no patient involvement, investigation findings 3200 incorrect data definition, investigation conclusions 58 cause traced to software coding.This issue occurred on the customer's test environment.The cardio report mappings were not active in a clinical production environment.There was no patient involvement.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
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: laura mccomis ; 900 walnut ridge drive; hartland, WI 53029 ; 2624248731
• MDR Report Key: 13864771
• Report Number: 2183926-2022-00005
• Device Sequence Number: 4715817
• Product Code: LLZ
• UDI-Device Identifier: 00842000100928
• UDI-Public: (01)00842000100928(10)12.1(11)210122
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K192276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 12.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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
• Patient Sex: Unknown