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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 09/07/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation found that the pulmonary artery z-scores were calculating correctly. However, the customer was expecting to see boston z-scores for the whole vessel pulmonary arteries and the knowledge base was using customer requested michigan z-scores for the proximal pulmonary arteries. This is a user error as the customer was adding data to the proximal pulmonary artery nodes and getting correct results for the proximal pulmonary arteries but they were expecting to see whole vessel pulmonary artery boston zscores. The reporting engineer removed the custom proximal pulmonary artery measurements nodes. 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 and stated that the pulmonary artery z-scores were not calculating as expected in their echo. Peds clinical report. With 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 indicated that there were no patients that were treated incorrectly based on the outcome of the perceived 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 Key6012923
MDR Text Key56971974
Report Number2183926-2016-00759
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 09/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2016
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 Received09/08/2016
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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