SIMVIEW THERAPY SIMULATOR 05497016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-28 for SIMVIEW THERAPY SIMULATOR 05497016 manufactured by Siemens Medical Solutions Usa, Inc..

Event Text Entries

[983932] A product issue has been reported with our simview therapy simulator. In the abundance of caution this issue is being reported. A screw fell off near image intensifier and hit a patient in the head requiring treatment of a minor injury cut above the eye. Should this failure re-occur serious injury is possible. There was an injury reported. Initial risk analysis is complete. Initial corrective action decision is pending.
Patient Sequence No: 1, Text Type: D, B5


[8160130] Risk assessment indicates a severity: 3 (critical) personal injury of head, even if weight of related part falling down is low. Worst case: eyes could be injured. Probability: b (improbable) maintenance instructions describe that the cassette holder and its proper fixation has to be checked on a monthly basis.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2910081-2009-00002
MDR Report Key1300385
Report Source05
Date Received2009-01-28
Date of Report2009-01-27
Date of Event2009-01-09
Date Mfgr Received2009-01-09
Device Manufacturer Date1999-04-01
Date Added to Maude2009-02-06
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 ContactMARK BURGESS
Manufacturer Street4040 NELSON AVENUE
Manufacturer CityCONCORD CA 94520
Manufacturer CountryUS
Manufacturer Postal94520
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIMVIEW THERAPY SIMULATOR
Generic NameSYSTEM, SIMULATION, RADIATION THERAPY
Product CodeKPQ
Date Received2009-01-28
Catalog Number05497016
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS MEDICAL SOLUTIONS USA, INC.
Manufacturer Address4040 NELSON AVE. CONCORD CA 94520 US 94520


Patients

Patient NumberTreatmentOutcomeDate
10 2009-01-28

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