SYNGO DYNAMICS 10091637

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-20 for SYNGO DYNAMICS 10091637 manufactured by Siemens Healthcare Gmbh.

MAUDE Entry Details

Report Number3002808157-2020-18118
MDR Report Key9732362
Report SourceUSER FACILITY
Date Received2020-02-20
Date of Report2020-02-03
Date of Event2020-01-29
Date Mfgr Received2020-02-03
Date Added to Maude2020-02-20
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 ContactANASTASIA SOKOLOVA
Manufacturer Street40 LIBERTY BLVD. MC 65-1A
Manufacturer CityMALVERN, PA
Manufacturer CountryUS
Manufacturer Phone4486478
Manufacturer G1SIEMENS HEALTHCARE GMBH
Manufacturer StreetHENKESSTRASSE 127
Manufacturer City91052
Manufacturer CountryGM
Manufacturer Postal Code91052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNGO DYNAMICS
Generic NamePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Product CodeLLZ
Date Received2020-02-20
Model Number10091637
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE GMBH
Manufacturer AddressHENKESSTRASSE 127 91052 GM 91052


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-20

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