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

Model Number	MERGE CARDIO V11.1.1
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported problem is currently under investigation by merge healthcare.The customer confirmed there were no allegations of patient harm due to this issue.This is still being investigated by support and development.When more information becomes available, a supplemental report will be submitted.
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 contacted merge healthcare and stated that diagnostic measurements (mr vena contracta and tr vena contracta) that were never taken on the modality were populating the cardio clinical report.Due to an incorrect values displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in harm.(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 (b)(6) 2020.Initial submission included that incorrect measurements and measurements that were never taken were population the cardio clinical report.Merge healthcare investigated this issue through a support request and post market product issue assessment.Investigation found the root cause of this issue to be due to misconfiguration of the affected systems caused by a change in the customer's environment where incoming measurements were mapped to the incorrect fields in the final report.An hhe was performed as there was no appropriate risk located in the risk document.The hhe found this issue to be an overall low risk for patient harm and the risk document was updated.The customer and support worked together to correct the measurement mapping strings which resulted in incorrect measurements on the clinical report.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.

• 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: 9548544
• Report Number: 2183926-2019-00028
• Device Sequence Number: 14024195
• Product Code: LLZ
• UDI-Device Identifier: 00842000100751
• UDI-Public: 00842000100751
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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 V11.1.1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1