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

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

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).

Manufacturer Narrative

Submitting this supplemental report to add fda correction and removal reference numbers.

• Brand Name: MERGE CARDIO
• Type of Device: SYSTEM, 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 Key: 5437555
• MDR Text Key: 38228038
• Report Number: 2183926-2015-00115
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO 10.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1403-2017; RES 76590
• Patient Sequence Number: 1