ACUITY H77

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-20 for ACUITY H77 manufactured by Varian Medical Systems Uk Ltd..

Event Text Entries

[2326045] Acuity adds a fluence to non imrt field, this fluence belongs to another pt. The customer reports seeing irreg plans with a zigzag line in bev, indicating the presence of a fluence. Eclipse does not show an mlc object in the focus window, even though the mlc outline is visible in the bev. In rt chart, the mlc object is visible and the mlc can be exported. However, in irreg the mlc cannot be imported into that field because eclipse thinks (rightfully) than an mlc is present. But something is not right with it. It can't be deleted because it's not visible in the first place. (it is also impossible to insert a new mlc). The customer reports that they had this happen with irreg plans on a couple of occasions and once it happened for a non-imrt ct-based plan which (after simulation) had a fluence attached to one of the fields. We recognized this fluence as belonging to a breast pt who had been simulated earlier that day (with irregular surface compensator fluence) and this allowed us to understand at least a little bit of what is going on. There was no serious injury reported.
Patient Sequence No: 1, Text Type: D, B5


[9398106] Although, there was no reported injury in this case, the available info suggest a possible malfunction of the device. Though still under investigation, varian has determined that a mdr is appropriate as this possible malfunction, should it recur, could potentially cause serious injury. Add'l f/u to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8020711-2011-00008
MDR Report Key2225490
Report Source01,05,06
Date Received2011-07-20
Date of Report2011-06-23
Date of Event2011-06-21
Date Mfgr Received2011-06-23
Device Manufacturer Date2004-11-01
Date Added to Maude2012-06-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHYSICIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMICHAEL PIGNATARO, MGR
Manufacturer Street911 HANSEN WAY M/S C-255
Manufacturer CityPALO ALTO CA 94304
Manufacturer CountryUS
Manufacturer Postal94304
Manufacturer Phone6504246471
Manufacturer G1VARIAN MEDICAL SYSTEMS UK LTD.
Manufacturer StreetGATWICK RD.
Manufacturer CityCRAWLEY, WEST SUSSEX RH109RG
Manufacturer CountryUK
Manufacturer Postal CodeRH10 9RG
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACUITY
Generic NameACCELERATOR, LINEAR, MEDICAL
Product CodeKPQ
Date Received2011-07-20
Model NumberH77
ID Number2.2.7
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVARIAN MEDICAL SYSTEMS UK LTD.
Manufacturer AddressUK


Patients

Patient NumberTreatmentOutcomeDate
10 2011-07-20

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