MRIDIAN SYSTEMS 20000, 10000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-22 for MRIDIAN SYSTEMS 20000, 10000 manufactured by Viewray, Inc..

MAUDE Entry Details

Report Number3011233554-2019-00006
MDR Report Key9363580
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-22
Date of Report2019-11-22
Date of Event2019-11-10
Date Mfgr Received2019-11-10
Date Added to Maude2019-11-22
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 FDA3
Event Location3
Manufacturer ContactMR. SEAN DELANEY
Manufacturer Street815 E. MIDDLEFIELD RD
Manufacturer CityMOUNTAIN VIEW CA 94043
Manufacturer CountryUS
Manufacturer Postal94043
Manufacturer Phone6502520920
Manufacturer G1VIEWRAY, INC.
Manufacturer Street815 E. MIDDLEFIELD RD.
Manufacturer CityMOUNTAIN VIEW CA 94043
Manufacturer CountryUS
Manufacturer Postal Code94043
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMRIDIAN SYSTEMS
Generic NameMRIDIAN SYSTEMS
Product CodeIYE
Date Received2019-11-22
Model Number20000, 10000
Catalog Number20000, 10000
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVIEWRAY, INC.
Manufacturer Address815 E. MIDDLEFIELD RD. MOUNTAIN VIEW CA 94043 US 94043


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-22

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