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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CARDIO SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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MERGE HEALTHCARE MERGE CARDIO SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number MERGE CARDIO 10.0
Device Problems Incorrect Measurement (1383); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2014
Event Type  malfunction  
Manufacturer Narrative
Submitting this supplemental report to add fda correction and removal reference numbers.
 
Manufacturer Narrative
Upon retrospective review, this issue was determined to be reportable as an mdr.
 
Event Description
Customer reported when measuring with the merge cardio toolbar, it displays cm on the workstation, but mm on the report. Ex: the rvot value sent from the cart is 1. 5cm. The units of measure in the ddocrreportdatatocpmap table are correct (cm) however the units of measure in the 17measurements. Xslt file are incorrect (mm). This causes the number in the report to display as 0. 15cm. When taking measurements from images on the cardio workstation or from the us cart, numbers are not crossing to the report in the correct unit of measure. Specifically, two measurements: right ventricular outflow tract (rvot) diameter and main pulmonary artery ed diameter. Since the two values are smaller than they are which can mislead the cardiologist that there are abnormality. The cardiologist could potentially prescribe unnecessary medications or treatment. (b)(4).
 
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Brand NameMERGE CARDIO
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge dr.
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge dr.
hartland WI 53029
Manufacturer Contact
michael diedrick
900 walnut ridge dr.
hartland, WI 53029
2629123570
MDR Report Key5437555
MDR Text Key192933813
Report Number2183926-2015-00115
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 Recall
Type of Report Initial,Followup
Report Date 02/15/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO 10.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/03/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 NumberZ-1403-2017; RES 76590

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