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

Model Number 10094141

Device Problem Loss of Power (1475)

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

Event Date 05/17/2016

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 the artis zee biplane system went down during a tavr procedure.The patient was safely removed from the system and transferred to an alternative system where the procedure was completed.We 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 non-conformity leading to the blockage of x-ray imaging was the result of an interrupted coolant flow when the fd cooling unit coupling failed.The couplings to connect the cooling circuit from the system to the system cabinet (incl.Fd cooling unit) are made of plastic.During exchange of the fd cooling unit the coupling has to be loosened by pressing the latch.As the plug and the mechanical structure around the latch are made of plastic the frame holding the latch can break when the applied force is too high.Siemens has initiated a field corrective action for this issue which has been reported to the fda via 806.10 report # 2240869-02/19/16-0006-c.This corrective action eliminates the root cause of the problem and prevents the possibility of reoccurrence.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, XRAY, 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: 5717099
• MDR Text Key: 48153930
• Report Number: 2240869-2016-43050
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2017
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1