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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 V11.1.1
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2020
Event Type  malfunction  
Manufacturer Narrative
A customer contacted merge healthcare and stated that they had incorrect and missing measurements on the clinical report. Support has been working with the customer to get the information needed to be able to investigate this issue. When more information becomes available a supplemental with be submitted.
 
Event Description
Indications for use: 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. Merge cardio is software comprised of modules that perform under standard "off the shelf" personal computers and servers running the (b)(4). Merge cardio is image data storage and display software that accepts dicom (digital imaging and communications in medicine) image data files from multiple modalities. It accepts text data using other standards-based formats including but not limited to hl7 and xml. Merge cardio is an internet/intranet network system that is designed for small and large, multi-user environments. The merge cardio network structure (including server and workstations) provides for the system's database management, storage, printing, and all dicom/hl-7 interface services. On (b)(6) 2020, a customer contacted merge healthcare and stated they were missing measurements and some measurements were incorrect. 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. Reference case (b)(4), 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 walnut ridge dr
hartland, wi
Manufacturer Contact
brian bell
75 binney st
cambridge, ma 
3540189
MDR Report Key9925049
MDR Text Key200830896
Report Number2183926-2020-00012
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
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 03/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V11.1.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2019
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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