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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 V10.1.2
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
The investigation found that the left main coronary artery unit of measure was listed in mm. This was causing the z-score to incorrectly calculate. Once the unit of measure for left main coronary artery was updated from mm to cm, the knowledge base correctly calculated the z-score. As a work around, the customer elected to utilize another device to calculate the z-score that. In merge cardio, the default unit of measure for coronary arteries in the 3. 4 and 3. 5 echo. Peds knowledge bases is cm, this customer requested to have their kb to have the coronary arteries unit of measure as mm. This customization caused the z-scores to calculate differently than expected. The reporting engineer has corrected the issue and the customer confirmed in the test environment prior to moving to production. The customer has confirmed correct results in production. The customer was contacted and no patients received incorrect care based on the outcome of the calculations.
 
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, a customer contacted merge healthcare alleging that the left coronary artery z-scores were not calculating correctly in their echo. Peds clinical report. Due to an incorrect value displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in harm. The customer was contacted and no patients were treated incorrectly based on the outcome of the incorrect value. (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
michael diedrick
900 walnut ridge dr.
hartland, WI 53029
2629123570
MDR Report Key5998947
MDR Text Key56451299
Report Number2183926-2016-00749
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 08/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V10.1.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

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