AXIOM ICONOS R200 5902775

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 2019-04-11 for AXIOM ICONOS R200 5902775 manufactured by Siemens Healthcare Gmbh.

Event Text Entries

[145915584] Table tilt controller and table side controller have been already exchanged at this site. The unit works as specified. Investigation is on-going. A supplemental report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[145915585] Siemens became aware of unintended table movements on the axiom iconos r200 unit. The x-ray table tilted from 90 degree to 0 degree position without given command. Siemens is not aware of any patient involvement in this case.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004977335-2019-70845
MDR Report Key8504197
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-04-11
Date of Report2019-02-18
Date of Event2019-02-18
Date Mfgr Received2019-04-10
Date Added to Maude2019-04-11
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 StreetSIEMENSSTR.1
Manufacturer CityFORCHHEIM, 91301
Manufacturer CountryGM
Manufacturer Postal Code91301
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAXIOM ICONOS R200
Generic NameIMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
Product CodeJAA
Date Received2019-04-11
Model Number5902775
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE GMBH
Manufacturer AddressSIEMENSSTR.1 FORCHHEIM, 91301 GM 91301


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-11

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