MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY ARTIS ZEE BIPLANE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10094141

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.During an emergency procedure the system went into bypass fluoro.Several attempts were made to reboot the system before it was functional again.The procedure was completed and are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The problem was identified as a hardware defect of the multi-display-manager (mdm).As a result of the error, the system went into bypass fluoro-mode.In the "bypass fluoro" mode the native x-ray image is available.With "bypass fluoro" a procedure may be continued with remaining functionality of the imaging system or even be terminated using the remaining functionality.The mdm has been exchanged the error did not recur since.The manufacturer is not considering further actions resulting from this event.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6420171
• MDR Text Key: 70741144
• Report Number: 2240869-2017-72878
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

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: No Information
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1