UMINOS AGILE MAX 10762472

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 2019-03-28 for UMINOS AGILE MAX 10762472 manufactured by Siemens Healthcare Gmbh.

Event Text Entries

[140164759] (b)(4). The investigation is on-going as the reported issue could not be reproduced by our technical experts. The log files were requested for further analysis. A supplemental report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[140164760] Siemens became aware of unintended system movement of the luminos agile max device. The digital imaging tower (dit) moved without control in longitudinal direction. There are no injuries attributed to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004977335-2019-74531
MDR Report Key8459688
Report SourceUSER FACILITY
Date Received2019-03-28
Date of Report2019-03-19
Date of Event2019-03-13
Date Facility Aware2019-03-19
Report Date2019-03-19
Date Reported to Mfgr2019-03-19
Date Mfgr Received2019-05-09
Device Manufacturer Date2018-02-01
Date Added to Maude2019-03-28
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 NameUMINOS AGILE MAX
Generic NameIMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
Product CodeJAA
Date Received2019-03-28
Model Number10762472
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 YR
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 2019-03-28

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