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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 V10.1.1.1
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/31/2016
Event Type  malfunction  
Manufacturer Narrative
Per merge healthcare support's investigation, the no value mean gradient calculation, is calculating correctly based on the formula coded within merge cardio. However, the customer prefers using an updated formula that is currently considered industry standard. A further investigation has been opened regarding this customer's allegation. When more information becomes available, a supplemental report will be submitted.
 
Event Description
Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information 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. On (b)(6) 2016, merge healthcare received an allegation from a customer indicating that the measurement tool on the cardio workstation provided inaccurate results for mean gradient. Merge investigated this allegation and determined that the customer was questioning the no value mean gradient calculation. All other mean gradient calculations were consistent with the customer's expectations. Potentially inaccurate calculations can lead to confusion by user(s) and may lead to incorrect treatment and/or a delay in care that may cause harm to a patient. According to the customer, the patient in which this issue was found, was not incorrectly diagnosed as they recognized the discrepancy and modified the value prior to completing the report. The physician stated that the measurement tool was only used rarely to manually calculate mean gradients. (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
meg mucha
900 walnut ridge dr.
hartland, WI 53029
2629123514
MDR Report Key5990416
MDR Text Key56034498
Report Number2183926-2016-00748
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,Followup
Report Date 08/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V10.1.1.1
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 Received06/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2016
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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