ARTIS VD 11C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for ARTIS VD 11C manufactured by Siemens Medical Solutions Usa, Inc..

Event Text Entries

[177966526] At 09:11 hours, ipp9 sent an error message to the monitors of: "limited table/stand movement". The table and ap flat detector moved significantly slow like it was in collision mode. All of the resets were complete with troubleshooting the room and the error did not clear. At this time, clinical imaging was in the core and witnessed with issue. A hard shut down and reboot of the room was then completed. The error still didn't clear, and the physician could not proceed with the procedure in ipp9. The intubated patient was then moved to another room for completion of the procedure. A service call was placed to siemen's and the service clinician came to assess the room. Manufacturer response for system, x-ray, fluoroscopic, image-intensified, (artis vd 11c) (per site reporter). The rep from siemens has not arrived yet.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9676042
MDR Report Key9676042
Date Received2020-02-06
Date of Report2019-12-16
Date of Event2019-12-13
Report Date2019-12-16
Date Reported to FDA2019-12-16
Date Reported to Mfgr2020-02-06
Date Added to Maude2020-02-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTIS VD 11C
Generic NameSYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Product CodeJAA
Date Received2020-02-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS MEDICAL SOLUTIONS USA, INC.
Manufacturer Address40 LIBERTY BOULEVARD MAILCODE: 64-1A MALVERN PA 19355 US 19355


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-06

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