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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VITAL IMAGES, INC. VITREA CT BRAIN PERFUSION PICTURE ARCHIVING AND COMMUNICATION

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VITAL IMAGES, INC. VITREA CT BRAIN PERFUSION PICTURE ARCHIVING AND COMMUNICATION Back to Search Results
Model Number VERSION 6.5.5
Device Problems Computer Software Problem (1112); Application Program Problem (2880)
Patient Problem Infarction, Cerebral (1771)
Event Date 08/25/2015
Event Type  Malfunction  
Manufacturer Narrative

The investigation is ongoing with user facility.

 
Event Description

On (b)(6) 2015, vital customer support received a call from (b)(6) regarding display of incorrectly inverted brain perfusion color maps (cbf and mtt) on our vitrea ct brain perfusion 4d software application. The reporter indicated that a delay in patient treatment had occurred because of the issue. Again on (b)(6) 2015, the same reporter informed our customer support team regarding another patient issue with the software in which the ct brain perfusion result from our software was not in agreement with the performed mr results. The mri showed an obvious stroke (infarct), while the ct perfusion results on our software did not. The patient was treated based on mri results.

 
Manufacturer Narrative

The customer has provided us two datasets to investigate. The results of the investigation identified two separate issues. Issue #1: unexpected mtt/cbf maps. This customer stated the mtt/cbf maps appear to be inverted. The investigation shows the dataset has a truncated scan, the time-density graph shows that there is not enough washout for our software to produce accurate results. From our neuro education and reference guide (vpmc-13505 a, page 122), we state "caution: factors that can affect the accuracy of the results are: ·not fully capturing the contrast bolus (including at least 2 seconds of pre-enhancement images and post-enhancement). " also, from our neuro education and reference guide (vpmc-13505 a, page 128), we instruct the user to review the time-density graph. Additionally, from our neuro education and reference guide (vpmc-13505 a, page 152), we provide examples of optimal and sub-optimal time-density graphs. In conclusion: the software has behaved as it is designed. Due to incomplete data, the perfusion results could not have been calculated accurately, although the software did produce accurate results with respect to the incomplete data. The software is designed to assist the user in this situation by prominently displaying the time-density graph and by providing accurate instructions for use on how to interpret the time-density graph. Issue #2: ct perfusion results do not agree with mr results for this issue, the user stated they were not confident in the results provided by our software and proceeded to perform an mr scan to obtain additional information. When the user reviewed the mr scan data, a clear infarct was shown, which was not shown by the ct perfusion results. A detailed investigation was done, the summary results are: the ct perfusion results from our software are in agreement with another vendor's algorithm, which suggests our software generated the results accurately based on the data. Additionally, a visual review of the cta data shows that the ct perfusion results are in agreement with the cta data, which suggests the software generated results accurately.

 
Event Description

On 08/25/2015, vital customer support received a call from (b)(6) regarding display of incorrectly inverted brain perfusion color maps (cbf and mtt) on our vitrea ct brain perfusion 4d software application. The reporter indicated that a delay in patient treatment had occurred because of the issue. Again on 08/26/2015, the same reporter informed our customer support team regarding another patient issue with the software in which the ct brain perfusion result from our software was not in agreement with the performed mr results. The mri showed an obvious stroke (infarct), while the ct perfusion results on our software did not. The patient was treated based on mri results.

 
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Brand NameVITREA CT BRAIN PERFUSION
Type of DevicePICTURE ARCHIVING AND COMMUNICATION
Manufacturer (Section D)
VITAL IMAGES, INC.
5850 opus pkwy suite #300
minnetonka MN 55343
Manufacturer (Section G)
VITAL IMAGES, INC.
5850 opus pkwy. suite #300
minnetonka MN 55343
Manufacturer Contact
alexis erazo
5850 opus pkwy. suite #300
minnetonka, MN 55343
9524879774
MDR Report Key5101924
MDR Text Key26728928
Report Number2134213-2015-00001
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVERSION 6.5.5
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/24/2015 Patient Sequence Number: 1
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