MAUDE Adverse Event Report: TOMTEC IMAGING SYSTEMS GMBH TOMTEC-ARENA TTA2; IMAGE REVIEW AND QUATIFICATION SOFTWARE

Model Number TTA2

Device Problem Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

A thorough evaluation of this event will be included in a follow-up report upon investigation completion.

Event Description

Customer reported that switching studies causes the measurement list to keep measurements from the previous study, and mixes them with those from the new one.Measurement list contains measurements from another study.

Manufacturer Narrative

This action was reported to fda per 21 cfr part 806 on 10/2/2019.Reference corrections and removal report number 8043836-10/02/19-001-c.

Manufacturer Narrative

This action was reported to fda per 21 cfr part 806 on 10/2/2019.Reference corrections and removal report number 8043836-10/02/19-001-c.

Manufacturer Narrative

A thorough technical investigation was performed which included evaluation of workflow details, a software design issue was determined to be to cause and a solution has been included in a newly released software revision.

• Brand Name: TOMTEC-ARENA TTA2
• Type of Device: IMAGE REVIEW AND QUATIFICATION SOFTWARE
• Manufacturer (Section D): TOMTEC IMAGING SYSTEMS GMBH; edisonstrasse 6; unterschleissheim, 85716 ; GM 85716
• MDR Report Key: 9087767
• MDR Text Key: 195108329
• Report Number: 8043836-2019-00002
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTA2
• Device Lot Number: 11.01
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 8043836-10/02/19-001-C
• Patient Sequence Number: 1