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U.S. Department of Health and Human Services

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

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TOMTEC IMAGING SYSTEMS GMBH TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUANTIFICATION SOFTWARE Back to Search Results
Model Number TTA2
Device Problem Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2019
Event Type  malfunction  
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 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.
 
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Brand NameTOMTEC-ARENA TTA2
Type of DeviceIMAGE REVIEW AND QUANTIFICATION SOFTWARE
Manufacturer (Section D)
TOMTEC IMAGING SYSTEMS GMBH
edisonstrasse 6
unterschleissheim, 85764
GM 85764
Manufacturer (Section G)
TOMTEC IMAGING SYSTEMS GMBH
edisonstrasse 6
unterschleissheim, 85764
GM 85764
Manufacturer Contact
gerald paul
edisonstrasse 6
unterschleissheim, 85764
GM   85764
MDR Report Key9328104
MDR Text Key206531175
Report Number8043836-2019-00003
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K150122
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberTTA2
Device Lot Number31.00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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