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

Model Number 10094135

Device Problems Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 08/10/2016

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.(b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee floor system.During a patient procedure, x-ray was blocked and an error message was shown.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 any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined as an arcing on the anode side of the x-ray tube.During the investigation the x-ray tube was disassembled and checked for high voltage stability.No abnormalities on the inner surfaces of the tube could be detected.The x-ray tube was replaced and the system was turned back over to the customer.No further errors have been reported.The measure taken is sufficient to solve the problem and to prevent the failure from recurring.

• Brand Name: ARTIS ZEE FLOOR
• 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, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5942604
• MDR Text Key: 54882816
• Report Number: 2240869-2016-04679
• 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: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10094135
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2016
• 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