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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 03/02/2020
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
The workflow triggering the event involves multiple systems: measurements are done on the ultrasound modality and then studies are sent in to enterprise imaging (ei) from agfa.From ei client the studies are opened in tomtec-arena from tomtec and the measurements are then exported via xml file to the cupid system from epic for reporting purpose.In some circumstances it happens that the measurements from the previous patient\study is sent additionally to epic cupid for the current one however with the current patients\study details.The software is used in clinical routine, there was no injury or serious deterioration of health state reported with this event.
 
Manufacturer Narrative
For this reported issue, only a small subset of measurements is affected which are passed through to a third party system.The images and measurment information that adds to diagnosis according to the guidelines of the societies are not affected so that the harm does result into an injury.For this reason, the serverity for this incident is rated level 1.An internal complaint analysis additionally provides evidence that there have not been reports about death or serious injuries so far.
 
Event Description
The workflow triggering the event involves multiple systems: measurements are done on the ultrasound modality and then studies are sent in to enterprise imaging (ei) from agfa.From ei client the studies are opened in tomtec-arena from tomtec and the measurements are then exported via xml file to the cupid system from epic for reporting purpose.In some circumstances it happens that the measurements from the previous patient\study is sent additionally to epic cupid for the current one however with the current patients\study details.The software is used in clinical routine, there was no injury or serious deterioration of health state reported with this event.First investigations show that the addition of previous measurement data to the current export is related to nonimagecomfindings (=imported measurements that are not mapped and displayed in the ei/tomtec-arena system but passed to the cupid system).It only happens in case of studies are launched without nonimagecomfindings and the previous launched study contained nonimagecomfindings.Also the configuration flag pass through measurements for tomtec-arena needs to be set to true and the integration scenario of tomtec-arena into a 3rd party system (tomtec-arena/ei in this case) applies a specific life-cycle mode.
 
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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, 85716
GM  85716
MDR Report Key9911027
MDR Text Key208329764
Report Number8043836-2020-00001
Device Sequence Number1
Product Code LLZ
UDI-Device Identifier04260361440143
UDI-Public(01)04260361440143(11)180223(10)21.07
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,health
Remedial Action Repair
Type of Report Initial,Followup
Report Date 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTTA2
Device Lot Number21.07
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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