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

Model Number	11.1.1
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
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 (b)(6) 2022, a customer contacted merge healthcare alleging that three measurements, coming from their imaging modality, were showing a different unit of measurement than the measurement units in merge cardio.Merge healthcare technical support was able to work with the customer regarding the alleged issue.It was determined that the units of measurement for one of the customer's modalities showed m/s however, the units of measurement, when imported into merge cardio, showed either cm/s or m/s.Technical support worked with the customer to resolve the issue with the three measurements and their units.The customer confirmed that the units were displaying as expected in merge cardio as cm/s.No further action is required at this time.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).
Additional Manufacturer Narrative
Merge healthcare technical support troubleshooted and investigated the customer's allegation of different units being shown on one of their imaging modalities versus the units showing differently in merge cardio.The root cause of the differing units could not be identified.The units discrepancy was identified by the customer after use of a ge device & a philips device/ imaging cart/modality.The units were consistent for the philips cart however, when the ge measurements and units were imported into merge cardio, they were inconsistent.The measurements on the ge cart showed m/s but when imported into merge cardio showed as either cm/s or m/s.Merge technical support worked with the customer to configure the ge cart measurements to import into merge cardio with units of cm/s.The customer was satisfied with the configuration change.There was no allegation of patient impact or harm as a result of this issue.No further action is indicated at this time.

• Brand Name: MERGE CARDIO
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dt; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer Contact: laura mccomis ; 900 walnut ridge dr; hartland, WI 53029 ; 2624248731
• MDR Report Key: 14850225
• Report Number: 2183926-2022-00009
• Device Sequence Number: 16739293
• Product Code: LLZ
• UDI-Device Identifier: 00842000100751
• UDI-Public: (01)00842000100751(10)11.1.1(11)190724
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2022

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: 11.1.1
• 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: 06/09/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown