ARTIS Q BIPLANE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-03 for ARTIS Q BIPLANE manufactured by Siemens Healthcare Gmbh.

MAUDE Entry Details

Report Number8956070
MDR Report Key8956070
Date Received2019-09-03
Date of Report2019-05-24
Date of Event2019-05-22
Report Date2019-05-24
Date Reported to FDA2019-05-24
Date Reported to Mfgr2019-09-03
Date Added to Maude2019-09-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTIS Q BIPLANE
Generic NameSYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Product CodeJAA
Date Received2019-09-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE GMBH
Manufacturer Address40 LIBERTY BOULEVARD MAILCODE: 65-1A MALVERN PA 19355 US 19355


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-03

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