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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE CARDIO PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS Back to Search Results
Model Number MERGE CARDIO V10.1.2
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2020
Event Type  malfunction  
Manufacturer Narrative
Customer called cardio technical support and stated that a report in merge cardio looked as if it was confirmed but it was actually just qc'd. Technical support was able to resolve this issue by flipping the confirmation state flag, in the database, back to qc in order for the report to be read by a physician. A review of the customer's device determined that there were no detailed activity logs, the only activity that could be seen from the logs was that the report was opened and then closed. With limited information available at the customer's site, technical support was unable to troubleshoot this issue for a primary cause. The customer did confirm that no patient harm resulted from this issue. The issue was resolved with a flag status change in the database which allowed a clinician to complete reading and reporting of the patient's images.
 
Event Description
Intended use: 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) 2020 a customer called merge cardio support stating that a patient's report was in a confirmed status when it was actually only in a qc status or a status where a clinician has not read the images and reported on their findings. Qc reports with the status of confirmed, if sent to the patient's physician, could lead to delay of treatment as the patient's images had not actually been reviewed and the findings documented in the report. The lack of the review and reporting may not be readily apparent to a physician. Reference complaint-(b)(4).
 
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Brand NameMERGE CARDIO
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland, wi
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnutridge dr
hartland, wi
Manufacturer Contact
brian bell
75 binney st
cambridge, ma 
3540189
MDR Report Key9857238
MDR Text Key200839287
Report Number2183926-2020-00009
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 02/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V10.1.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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