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

Model Number	11.1.1
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
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) 2021, a customer contacted merge healthcare to report that two reports were not available for viewing.Merge healthcare support found that the reports were never confirmed but were in confirmed status.The logs had been truncated so they were unavailable for troubleshooting purposes.Support manually reset the status of the reports and they were then able to be read and confirmed by the physician.No further action is necessary 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
This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 9/24/2021.As of 9/28/2021, merge healthcare is ceasing reporting on merge cardio report status sync issues.The issue in question presents when a report is in a confirmed status in the database but was not confirmed by the physician.This issue is caused by network issues and not caused by or contributed to by merge cardio in any way.Review of this issue based on current knowledge of the device, clinical workflow, existing mitigations against user errors, and the presence of no death or injury associated with the issue at any point between 2016 and 2021 indicates that the device is operating as designed and that this issue presents remote likelihood of injury or harm to a patient.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.H10 - additional narrative/data.

• Brand Name: MERGE CARDIO
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• MDR Report Key: 12527028
• Report Number: 2183926-2021-00026
• Device Sequence Number: 14508380
• 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: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 09/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• 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