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	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer called and stated that a report in merge cardio looked as if it was confirmed but it was actually just qc'd.Merge healthcare technical support was able to resolve this issue by changing the confirmation state in the database back to qc.This change of status in the database allows the report to be read by a physician.Technical support was unable to troubleshoot this issue for root cause because, at the time of investigation, no recent report change/status logs were left to be investigated.These older transaction logs had been truncated due to their age and were replaced with more recent transaction history information.Merge healthcare personnel have made several attempts to contact the customer for additional information regarding the reports incorrect status, but the customer has not yet responded.If additional information is provided from the customer or if root cause can be determined a supplemental report will be filed.
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) 2019 a customer called merge cardio support stating there was a report was in confirmed status when it was actually only qc status.Qc reports with the status of confirmed could lead to delay of treatment as the report has not actually been read by a physician.The incorrect status of the report may not be readily apparent to a user.There has been no allegation of an injury or impact to a patient as a result of this issue.Reference 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: 8470571
• Report Number: 2183926-2019-00010
• Device Sequence Number: 1062490
• 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
• Report Date (Section B): 03/05/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1