BRIT VISION PACS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-28 for BRIT VISION PACS manufactured by Brit Systems Inc.

Event Text Entries

[21016549] (b) (4). Brit systems pacs version 3. 5. 5 - (b) (6) 2009 - brit system inc.... : many functions with tabs do not work as expected or fail to reliable work as expected. I am unaware which are required features or whether features on the system are required to work. I am not sure if this is only my institution but review. Does not allow for automated ultrasound measurement on brit pacs and gives pixel number. Tabs designed to determine how comparison images are pulled do not allow for reliable and appropriate comparisons to be automatically cued for comparison. They simply for the most part often set the incorrect comparison. Cannot link current and comparison for easy image to image comparison as it works by slice number and not table position. Should be linked by table position. This makes it cumbersome to compare two lymphoma studies of different slice thickness. Reference lines are not reliable and often the corresponding plane position incorrectly. Does not allow for drag and drop of series of ct, etc. If you drag an axial serious form thumbnail, the other windows usually change. If you bang to a single image or back to multi window format, the window setting changes - does not keep you or setting often. Mpr features have glitches. The report viewer does not respect the powerscribe dictation format... The text is slammed together with all caps making it more difficult to read. I do not know if this is brit or coming from our vista.. But it does do all caps regardless, so you cannot stress abnormalities with caps for recognition when reading the report. You cannot do ct hanging protocols of the same axial acquisition at different windows-bone, medias, lung- due to the lack of appropriate drag and drop... Because when you drag and drop, the multiwindows are interconnected and it changes the window settings on the other images without the user input. If you get lucky and get it to do, do, so the minute you click and image the others are altered. Example if you pull a thumbnail down to a square often the other boxes change sometimes dropping the other series. Has difficulty with split studies... Does not allow more than two exams dates on a single monitor... I think there are more... I sat with brit for several hours and i was told they are aware of these, but it was too much code to fix these problems. That they are working on a new system and they do not want to take the time to fix these things.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5015727
MDR Report Key1672748
Date Received2010-04-28
Date of Report2010-04-28
Date Added to Maude2010-05-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBRIT VISION PACS
Generic NameNA
Product CodeLMD
Date Received2010-04-28
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerBRIT SYSTEMS INC
Manufacturer Address1909 HI LINE DR STE A DALLAS TX 75207 US 75207


Patients

Patient NumberTreatmentOutcomeDate
10 2010-04-28

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