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

Model Number	TTA2
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.
Event or Problem Description
It was reported that while using tomtec-arena zero if two tabs are open on the browser at the same time, if the user switches from one tab to the other, then the patient information from the first tab is copied to the patient study on the second tab.To date no adverse events have been reported as a result of this issue.
Additional Manufacturer Narrative
An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.
Event or Problem Description
It was reported that while using tomtec-arena zero if two tabs are open on the browser at the same time, if the user switches from one tab to the other, then the patient information from the first tab is copied to the patient study on the second tab.To date no adverse events have been reported as a result of this issue.

• Brand Name: TOMTEC-ARENA TTA2
• Common Device Name: IMAGE REVIEW AND QUANTIFICATION SOFTWARE
• Manufacturer (Section D): TOMTEC IMAGING SYSTEMS GMBH; edisonstrasse 6; unterschleissheim, 85764 ; GM 85764
• MDR Report Key: 9328104
• Report Number: 8043836-2019-00003
• Device Sequence Number: 2616609
• Product Code: LLZ
• UDI-Device Identifier: 04260361440143
• UDI-Public: (01)04260361440143(11)190730(10)31.00
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: Other
• Device Model Number: TTA2
• Device Lot Number: 31.00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1