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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 01/15/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation found that an echo cart was taking forty plus measurements for strain, the measurement for strain (gls, 2d) was not populating with the desired value. Support found the correct value that the customer wanted mapped. Support unmapped the string that was crossing into the report and mapped the desired string that the customer was looking for. The customer also requested that the value be rounded to the tenth decimal place and also not be shown as an absolute value. Support configured the string to populate to the tenth decimal place and without absolute value as requested. The site did not verify mapping before go live. After they went live they noticed it. This issue was resolved by support and loaded to their test system for validation. The correct strain measurement has been uploaded to production and this issue was resolved. The customer confirmed that no patients were harmed due to this issue. This was noticed right away after go live and the site had a work around in place while this was being corrected by support. Customer confirmed that this issue has been resolved.
 
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 microsoft windows 2000/2003/xp operating systems. 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 that the measurement for strain is not correct (gls, 2d). 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 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
brian bell
75 binney st
cambridge, MA 02142-1123
3123540189
MDR Report Key9681178
MDR Text Key200842105
Report Number2183926-2020-00003
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
Report Date 01/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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