BRILLIANCE AIR 40/64/UCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-16 for BRILLIANCE AIR 40/64/UCT manufactured by Philips Medical Systems (cleveland), Inc..

MAUDE Entry Details

Report Number1525965-2020-00001
MDR Report Key9596311
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-16
Date of Report2019-12-24
Date Mfgr Received2019-12-24
Date Added to Maude2020-01-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DERRICK MASSURI
Manufacturer Street595 MINER RD
Manufacturer CityCLEVELAND OH 44143
Manufacturer CountryUS
Manufacturer Postal44143
Manufacturer Phone4404833000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBRILLIANCE AIR 40/64/UCT
Generic NameSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Product CodeJAK
Date Received2020-01-16
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
Manufacturer Address595 MINER RD CLEVELAND OH 44143 US 44143


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.