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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 V11.0
Device Problems Application Program Problem: Parameter Calculation Error (1449); Data Problem (3196)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2020
Event Type  malfunction  
Manufacturer Narrative
An internal issue was found during new version testing that vein leg measurements for length populate the depth field in the vein table for vascular reporting in the 5. 0 kb version. This issue has never been reported by a customer. The investigation and any corrections are still in progress. A supplemental will be submitted when new information is available.
 
Event Description
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. On (b)(6) 2020, during internal testing of a new release by merge healthcare, it was found that the length measurements import to the depth location in the vein measurement table for the vein anatomy of the leg. This occurs in the 5. 0 version of vascular reporting which is currently in cardio versions 11. 0-12. 0. 1. Depth measurements currently do not map so they were not overwritten. The issue is that length measurements populate the depth fields. This was found to impact all of the veins for lower extremities. There have been zero reports of this issue by a customer. Due to length measurements populating the depth field, there is a potential for misdiagnosis. However, there are zero reports of impact to a patient and no customers have reported this issue. 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 Key9952834
MDR Text Key200828171
Report Number2183926-2020-00013
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V11.0
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 Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2017
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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