SYNGO DYNAMICS 10091805

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-29 for SYNGO DYNAMICS 10091805 manufactured by Siemens Healthcare Gmbh.

MAUDE Entry Details

Report Number3002808157-2018-24929
MDR Report Key8560712
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-04-29
Date of Report2018-04-06
Date of Event2018-04-06
Date Mfgr Received2018-04-06
Date Added to Maude2019-04-29
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 DYNAMICS
Generic NamePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Product CodeLLZ
Date Received2019-04-29
Model Number10091805
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 2019-04-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.