SOMATOM PERSPECTIVE 10891666

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-28 for SOMATOM PERSPECTIVE 10891666 manufactured by Siemens Shanghai, Medical Equipment Ltd..

MAUDE Entry Details

Report Number3003202425-2019-01895
MDR Report Key9244978
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-28
Date of Report2019-10-04
Date of Event2019-10-04
Date Mfgr Received2019-10-04
Date Added to Maude2019-10-28
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 ContactREBECCA TUDOR
Manufacturer Street40 LIBERTY BLVD. 65-1A
Manufacturer CityMALVERN PA 19355
Manufacturer CountryUS
Manufacturer Postal19355
Manufacturer Phone6104486484
Manufacturer G1SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.
Manufacturer Street278 ZHOU ZHU RD.
Manufacturer CitySHANGHAI, 201318
Manufacturer CountryCH
Manufacturer Postal Code201318
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOMATOM PERSPECTIVE
Generic NameSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Product CodeJAK
Date Received2019-10-28
Model Number10891666
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.
Manufacturer Address278 ZHOU ZHU RD. SHANGHAI, 201318 CH 201318


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-28

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