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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH ARTIS BIPLANE C-ARM SYSTEM; SYSTEM, X-RAY, ANGIOGRAPHIC
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SIEMENS AG/SIEMENS HEALTHCARE GMBH ARTIS BIPLANE C-ARM SYSTEM; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number 553921
Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2017
Event Type  malfunction  
Event Description
During a vertebral aspiration on a patient the i-guide software package on the siemens biplane machine did not function properly.The software stated that all angles were unachievable.Therefore the physician had to manually drive his needle to the entry point without the 3d operations.The physician was able to get the specimen needed, however additional radiation was needed.An extra 16cc of contrast was given.The siemens applications specialist was informed and was able to confirm that the application was not operating appropriately.The manufacturer came on-site to evaluate the device and fix the problem.
 
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Brand Name
ARTIS BIPLANE C-ARM SYSTEM
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
Manufacturer (Section D)
SIEMENS AG/SIEMENS HEALTHCARE GMBH
40 liberty boulevard
mailcode: 65-1a
malvern PA 19355
MDR Report Key6547130
MDR Text Key74515223
Report Number6547130
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number553921
Other Device ID Number1734
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/01/2017
Event Location Hospital
Date Report to Manufacturer05/01/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age34 YR
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