SYNGO.PLAZA 10863171

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-07-30 for SYNGO.PLAZA 10863171 manufactured by Siemens Healthcare Gmbh.

MAUDE Entry Details

Report Number3002808157-2019-91115
MDR Report Key8842252
Report SourceFOREIGN,USER FACILITY
Date Received2019-07-30
Date of Report2019-07-16
Date of Event2019-07-15
Date Mfgr Received2019-07-16
Date Added to Maude2019-07-30
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 ContactANASTASIA SOKOLOVA
Manufacturer Street40 LIBERTY BLVD, MC 65-1A
Manufacturer CityMALVERN PA 19355
Manufacturer CountryUS
Manufacturer Postal19355
Manufacturer Phone6104486478
Manufacturer G1SIEMENS HEALTHCARE GMBH
Manufacturer StreetHENKESTRASSE 127
Manufacturer CityERLANGEN, 91052
Manufacturer CountryGM
Manufacturer Postal Code91052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNGO.PLAZA
Generic NamePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Product CodeLLZ
Date Received2019-07-30
Model Number10863171
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE GMBH
Manufacturer AddressHENKESTRASSE 127 ERLANGEN, 91052 GM 91052


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-30

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