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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE BIPLANE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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SIEMENS HEALTHCARE GMBH ARTIS ZEE BIPLANE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Catalog Number 10848364
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Insufficient Information (4580)
Event Date 05/04/2021
Event Type  malfunction  
Event Description
Patient was in room for a diagnostic cerebral angiogram with a 3d reconstruction.When setting up for 3d, the machine produced an error code and would not allow further movement to set up for the spin.We tested many typical reasons for malfunction, none remedied the issue.We restarted the machine and the error code was still present.We reached out to the gentleman who normally works on our machines.Followed some instructions from him and still no fix.This 3d was critical for the patient and we were not able to obtain the 3d at this time.Once the gentleman ran some diagnostics on our machine, the error code mentioned that the image intensifier didn't know where it was in space.There was no way to know this error message correlated with this part of the machine until diagnostics were run.
 
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Brand Name
ARTIS ZEE BIPLANE
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
40 liberty boulevard
mailcode: 65-1a
malvern PA 19355
MDR Report Key11912352
MDR Text Key253509095
Report Number11912352
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10848364
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/04/2021
Event Location Hospital
Date Report to Manufacturer06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age14965 DA
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