TOMOTHERAPY HD 390

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-12 for TOMOTHERAPY HD 390 manufactured by Accuray.

Event Text Entries

[97715214] As required by the (b)(6) state rules and regulations, we are writing to inform you of a recent documentation error due to a defect in accuray tomography equipment software. The error did not result any patient harm or inadvertent treatment. The glitch was contained in the software and was monitored daily by staff. The accuray manufacturer resolved the issue by (b)(6) 2018 and no further issues have been reported. On (b)(6) 2017 - therapists noticed that the number of fractions reported in aria (electronic medical record) is one less than the true number of fractions reported in tomotherapy. Therapists informed physicists immediately. On (b)(6) 2017 - physicists confirmed that the rt records were not automatically exported by the ois to aria since (b)(6) 2017. Physicists exported all fractions from (b)(6) manually. The problem was reported to radoncit department and administration. At manual import of fractions it was noticed that one patient's records showed double the amount of dose actually delivered. On (b)(6) 2017 - accuray and varian customer support lines were called to assist. On (b)(6) 2017 - therapists noticed that 'elapsed days' for patients who started treatment before december 1 is about 30 days longer than the true number of elapsed days. Therapists informed physicists. On (b)(6) 2017 - accuray, varian and administration were made aware of the problem with the discrepancy in 'elapsed days'. On (b)(6) 2017 - accuray sent out a customer supplement outlining the issues described above. On (b)(6) 2018 - issue resolved by accuray. No further issues noted. Please do not hesitate to contact me for any questions or concerns at (b)(6). Cordially, (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5074581
MDR Report Key7193998
Date Received2018-01-12
Date of Report2018-01-08
Date of Event2017-12-01
Date Added to Maude2018-01-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTOMOTHERAPY HD
Generic NameTOMOTHERAPY
Product CodeMUJ
Date Received2018-01-12
Model Number390
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerACCURAY


Patients

Patient NumberTreatmentOutcomeDate
10 2018-01-12

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