MAUDE Adverse Event Report: ECHOPIXEL, INC. TRUE 3D VIEWER SOFTWARE

Model Number	EP-00003
Medical Device Problem Code	Programming Issue (3014)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
No known event occurred.Problem: the import of enhanced ultrasound formatted data (nema dicom supplement 43: storage of 3d ultrasound data, version: final text - (b)(6) 2009), can result in incorrect display of image orientation.The reason was an incorrect understanding of the data format.This fault does not reside in the true 3d render engine, but rather is localized to the dicom input task of the application problem: the import of philips 3ddcm formatted ultrasound images can result in incorrect display of image orientation.The reason was an incorrect understanding of the data format.This fault does not reside in the true 3d render engine, but rather is localized to the dicom input task of the application.Issue was identified on release versions: 1.6.1 and 1.6.2.

• Brand Name: TRUE 3D VIEWER SOFTWARE
• Common Device Name: TRUE 3D VIEWER
• Manufacturer (Section D): ECHOPIXEL, INC.; 4677 old ironsides drive; suite 445; santa clara CA 95054
• MDR Report Key: 7290502
• Report Number: 3011501361-2018-00001
• Device Sequence Number: 11035524
• Product Code: LLZ
• UDI-Device Identifier: 00851325007003
• UDI-Public: 00851325007003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EP-00003
• Device Catalogue Number: TRUE 3D VIEWER SOFTWARE
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1