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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.
 
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 Name
TOMTEC-ARENA TTA2
Type of Device
IMAGE REVIEW AND QUANTIFICATION SOFTWARE
Manufacturer (Section D)
TOMTEC IMAGING SYSTEMS GMBH
edisonstrasse 6
unterschleissheim, 85764
GM  85764
MDR Report Key9328104
MDR Text Key206531175
Report Number8043836-2019-00003
Device Sequence Number1
Product Code LLZ
UDI-Device Identifier04260361440143
UDI-Public(01)04260361440143(11)190730(10)31.00
Combination Product (y/n)N
PMA/PMN Number
K150122
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was 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
Date Manufacturer Received10/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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