MAUDE Adverse Event Report: SIEMENS AG, MEDICAL SOLUTIONS ARTIS ZEE BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY

Model Number 10521008

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 12/15/2013

Event Type  malfunction  

Event Description

Multiple issues in 2013 with defective components and 3d program configuration of artis zee biplane system.These issues require the following major repairs: defective detector, defective table pot (ih), a continuing with zero problem with 3d, corrupted data base (ih), complete room evaluation and adjustment diamentor problem and replacement of diamentor cable and chamber.
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manufacturer response for interventional fluoroscopy x-ray system, artis zee biplane system (per site reporter)
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the following corrective actions were performed in response to problem the system evaluation findings.Performed adjustment on system dose & dexi on both a & b planes.Completed 3d calibration & checked with fast wire test.The a-plane diamentor was out of tolerance and would not calibrate.Replaced diamentor and attempted calibration - failed.Replaced cable and attempted calibration- failed.Ordered and replaced ion chamber.Calibrated both a & b plane ion chambers, diamentors and shindose's.All successful and system tested ok.In addition, the zero problem with 3d program can be addressed with proper operator set up of which is similar but different than older artis zee system models.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY
• Manufacturer (Section D): SIEMENS AG, MEDICAL SOLUTIONS; 51 valley stream pkwy.; malvern PA 19355
• MDR Report Key: 4096177
• MDR Text Key: 4704438
• Report Number: 4096177
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/11/2014

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: Invalid Data
• Device Model Number: 10521008
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2014
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1