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

Model Number	MERGE CARDIO V10.3
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report has been confirmed and exported to the emr.The customer stated that this could cause delay in care and could cause harm but has not alleged or confirmed that a patient was affected at this time.When patient safety can be determined and a root cause and/or fix can be established, a supplemental will be filed.For this reason, (b)(4) was used.
Event or Problem Description
Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information 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.On (b)(6) 2018, the customer alleged the report was not going to their emr.Upon investigation, it was found that the reason the report never exported to the customer's emr, epic.This was due to it being incorrectly in confirmed status instead of being in qc status and actually confirmed.Merge cardio support corrected the issue by changing the status in the database qc reports with the status of confirmed could lead to delay of treatment as it has not actually been read by a physician and as a result may not be readily apparent to a clinician.However, there have been no allegations of harm as a result of this issue.(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 11/27/2018.Initial submission found that a report was not exported to a customers emr system, upon further investigation it was found that the report was in confirmed status but was never confirmed, support updated report status to qc to allow for the report to be read and exported.Further investigated found this was due to a software defect vrcs-11374 and is resolved in a later version of cardio.This issue lead to a delay in the exam being read but no allegation of patient safety issues due to the delay.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: 104 - software problem identified.Conclusions code: 12- cause traced to device design.H10 - indication of additional manufacturer information is contained in this follow-up report.

• 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: 8109331
• Report Number: 2183926-2018-00094
• Device Sequence Number: 2364064
• Product Code: LLZ
• UDI-Device Identifier: 00842000100041
• UDI-Public: 00842000100041
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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 V10.3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1