CLEARCANVAS RIS/PACS PERSONAL EDITION WORKSTATION 13.1 SYN-0524

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-02 for CLEARCANVAS RIS/PACS PERSONAL EDITION WORKSTATION 13.1 SYN-0524 manufactured by Synaptive Medical Inc..

MAUDE Entry Details

Report Number3012075008-2020-00001
MDR Report Key9777538
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-02
Date of Report2020-03-02
Date of Event2017-01-20
Date Mfgr Received2020-02-04
Device Manufacturer Date2017-11-06
Date Added to Maude2020-03-02
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 ContactMS MAHAM ANSARI
Manufacturer Street555 RICHMOND STREET W SUITE 800
Manufacturer CityTORONTO, ON M5V3B1
Manufacturer CountryCA
Manufacturer PostalM5V3B1
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCLEARCANVAS RIS/PACS
Generic NameSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Product CodeLLZ
Date Received2020-03-02
Model NumberPERSONAL EDITION WORKSTATION 13.1
Catalog NumberSYN-0524
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSYNAPTIVE MEDICAL INC.
Manufacturer Address555 RICHMOND STREET W. SUITE 800 TORONTO, ON M5V 3B1 CA M5V 3B1


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-02

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