Philips Expression MR400 - Page 409

ExpressionMR400InstructionsforUse GuidelinesandReferencesE‐5
ShellockFG.MRsafetyupdate2002:Implantsanddevices.JournalofMagneticResonance
Imaging2002;16:485‐496.
ShellockFG.Radiofrequency‐inducedheatingduringMRprocedures:Areview.Journalof
MagneticResonanceImaging2000;12:30‐36.
ShellockFG.ReferenceManualforMagneticResonanceSafety:
2003Edition,Amirsys,Inc.,2003.
ShellockFG,SlimpG.SevereburnofthefingercausedbyusingapulseoximeterduringMRI.
AmericanJournalofRoentgenology1989;153:1105.
ShellockFG,HatfieldM,SimonBJ,BlockS,WamboldtJ,StarewiczPM,PunchardWFB.
Implantablespinalfusionstimulator: assessmentofMRIsafety.Journalof
MagneticResonance
Imaging2000;12:214‐223.
SmithCD,NyenhuisJA,KildishevAV.Healtheffectsofinducedelectricalfields:implicati onsfor
metallicimplants.In:ShellockFG,ed.Magneticresonanceprocedure:healtheffectsandsafety.
BocaRaton,FL:CRCPress,2001;393‐414.
U.S.FoodandDrugAdministration,CenterforDevicesandRadiologicalHealth(CDRH),
Medical
DeviceReport(MDR)(http://www.fda.gov/CDRH/mdrfile.html).Thefilescontaininformation
fromCDRH'sdeviceexperiencereportsondeviceswhichmayhavemalfunctionedorcauseda
deathorseriousinjury.ThefilescontainreportsreceivedunderboththemandatoryMedical
DeviceReportingProgram(MDR)from1984 ‐1996,andthevoluntaryreportsupto
June1993.
Thedatabasecurrentlycontainsover600,000reports.
U.S.FoodandDrugAdministration,CenterforDevicesandRadiologicalHealth(CDRH),
ManufacturerandUserFacilityDeviceExperienceDatabase,MAUDE,(http://www.fda.gov/cdrh/
maude.html).MAUDEdatarepresentsreportsofadverseeventsinvolvingmedicaldevices.The
dataconsistsofallvoluntaryreportssinceJune,1993,user
facilityreportssince1991,distributor
reportssince1993,andmanufacturerreportssinceAugust,1996.