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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 V10.0
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2020
Event Type  malfunction  
Manufacturer Narrative
An investigation identified an error in the calculations for michigan reference ranges and z-scores. Merge healthcare / (b)(4) is working with the pediatric echo knowledge base supplier ascend in order to complete the investigation. The investigation is ongoing and when more information becomes available, a supplemental report will be filed. At this time there are no allegations of patient impact or harm due to the error in the calculated z-scores.
 
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 (b)(4) 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, merge healthcare was performing internal testing of a new 5. X pediatric echo knowledge base file for michigan z-scores. It was found that while testing this version 5. X file and comparing with the previously released version 3. X file for michigan z-score calculations, that there was a difference between the two. Both the internal merge healthcare investigation and the paediatric echo knowledge base supplier ascend's investigation concluded that there was an error and that the michigan reference ranges and z-scores are not calculating correctly. For customers using a 3. X version of the ascend pediatric echo knowledge base to calculate michigan z-scores, there is a potential for a misdiagnosis which may lead to patient harm. However, there have been no reports of patient injury or harm as a result of this issue. Reference complaint-(b)(6).
 
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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 Key9997097
MDR Text Key199903156
Report Number2183926-2020-00016
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V10.0
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 Received05/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2183926-05/06/2020-001-C

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