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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 10/24/2017
Event Type  malfunction  
Manufacturer Narrative
To resolve this customer's issue, merge healthcare's clinical reporting technician configured the ascend database to produce the correct michigan reference ranges. At this time there are no allegations of patient impact or harm due to the error in the calculated reference ranges. Merge healthcare's investigation confirmed that the defect resides within supplier ascend 3. X database. This database is installed with merge cardio customers requesting reference ranges & z-scores for paediatric cardiology. As a result of the investigation, merge healthcare is voluntarily conducting a field action or recall: 2183926-05/06/2020-001-c.
 
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. In (b)(6) 2020 merge healthcare initiated an investigation for an internally identified discrepancy in pediatric echography michigan z-score reference ranges. These reference ranges are calculated by a suppliers's database that is installed with the merge cardio product. Both merge healthcare and the peadiatric echo knowledge base supplier ascend's investigation concluded that there was an error and that the michigan reference ranges were not calculating correctly. Ascend's 3. X version of their pediatric echo knowledge base calculates michigan reference ranges incorrectly. This defect results in wider than expected upper and lower limit reference ranges. Therefore, when a patient's z-score, for a particular measurement, is evaluated against the range, a false negative may be indicated by the wider range of acceptable reference range values. As a result of this reference range miscalculation, 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. Due to the michigan z-score reference range investigation and supplier ascend confirming a defect in their pediatric echo database, a historical analysis of service requests and complaints submitted to merge healthcare was performed. A record with similar information to the reference range investigation was identified and reassessed. On (b)(6) 2017, a request for information came in from a merge cardio customer. The customer was requesting additional information for the reference ranges related to z-scores. Due to the customer requesting information about how the reference ranges were calculated, this record was classified, at the time, as not a complaint. However, with the confirmation from supplier ascend that there is a defect in their 3. X database's calculation of michigan reference ranges, this historical record has been re-evaluated and determined to meet the definition of a complaint and therefore, meets malfunction reporting requirements. The customer did not allege any injury or impact to patients. Merge healthcare technical support worked with the customer and configured their database to produce the expected michigan reference ranges. The customer's request was resolved. This historical record is being reported because of an investigation determined that confirmed a defect resides in supplier ascend's database. Merge healthcare's supplier ascend confirmed the defect on (b)(6) 2020. 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 walnut ridge drive
hartland, wi
Manufacturer Contact
brian bell
75 binney street
cambridge, ma 
3540189
MDR Report Key10039363
MDR Text Key195738574
Report Number2183926-2020-00019
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 05/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V10.0
Device Catalogue Number10.1.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Yes
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
Removal/Correction Number2183926-05/06/2020-001-C

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