ACUITY H77-SIM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-03 for ACUITY H77-SIM manufactured by Varian Medical Systems.

Event Text Entries

[1482729] The customer reported that when a digital shape projector (dsp) /field aperture shape is created, the position of the shape displayed on the vision monitor (control console area), is different from the actual dsp shape position displayed on the couch/pt. This shape position error occurs only when the collimator angle is at a value other than 0 degrees. The error is a rotational shift of 90 degrees between the actual shape on the couch and that displayed on the vision monitor. When the collimator is rotated back to zero degrees, the discrepancy disappears. No serious injury to the pt was reported.
Patient Sequence No: 1, Text Type: D, B5


[8592605] Though still under investigation, varian has determined that a mdr is appropriate, as this malfunction, should it recur, could potentially cause a serious injury. Additional follow-up to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8020711-2009-00010
MDR Report Key1632468
Report Source05,06
Date Received2010-03-03
Date of Report2009-12-09
Date of Event2009-12-05
Date Mfgr Received2010-02-04
Device Manufacturer Date2008-09-01
Date Added to Maude2011-04-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDAVID HALL, MGR
Manufacturer Street911 HANSEN WAY
Manufacturer CityPALO LATO CA 94304
Manufacturer CountryUS
Manufacturer Postal94304
Manufacturer Phone6504833153
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 NameSIMULATOR
Product CodeKPQ
Date Received2010-03-03
Model NumberH77-SIM
ID NumberV8.9
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVARIAN MEDICAL SYSTEMS
Manufacturer AddressPALO ALTO CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2010-03-03

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