RAYSTATION 9A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for RAYSTATION 9A manufactured by Raysearch Laboratories Ab (publ).

Event Text Entries

[173746233] We are occasionally getting errors transferring patient ct scans into the radiation treatment planning system raystation 9a. We have seen this issue few more times. We had not seen this error prior to upgrading to version 9a. We have notified raysearch of the problem, but so far they have been unable to solve it. They also say that we are not the only customer to report this issue. Generally, we just re-try the import and it works. The fact that it is not reproducible (i. E. It doesn? T happen ever to me for a single patient nor for every patient) makes it difficult for raysearch to diagnose. During one of these issues, i looked at the number of files being exported from mim, in dicom scp, and number of files (ct slices) being shown in raystation import screen. I noticed that both mim dicom scp had same number of files but raystation import screen showed one less file. Obviously the export failed. When we tried again as in our workaround, the import was successful and this time raystation import showed correct number of files. We have verified (with the help of a raysearch specialist) that all files are being exported from mim to raystation. The issue seems to be on the raystation side importing the ct slices. Troubleshooting procedure that we did: checked that the number of ct slices in mim and rs storage scp matched? Determined that ct series were imported into raystation with 1 missing slice. Structure set was not imported. We tried to import all the files again? Not successful. We tried to import just the structure set? Not successful (even if this worked, we still need to get all ct slices into rs for treatment planning). Tried deleting the ct series in rs then re-import? Successful import if all files. We didn? T resend the files from mim. Those files are the same ones that were exported to raystation scp with the first attempt. (b)(6) has been working with us to solve the problem. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5091983
MDR Report Key9539708
Date Received2019-12-31
Date of Report2019-12-30
Date of Event2019-11-07
Date Added to Maude2020-01-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAYSTATION 9A
Generic NameSYSTEM, PLANNING, RADIATION THERAPY TREATMENT
Product CodeMUJ
Date Received2019-12-31
Model Number9A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRAYSEARCH LABORATORIES AB (PUBL)


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-31

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