MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY AXIOM ARTIS ZEEGO; INTERVENTIONAL, FLUOROSCOPIC, XRAY SYSTEM

Model Number 10280959

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

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

Event Date 08/25/2016

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.This event occurred in (b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zeego system.The customer reported an error message "tube too hot" while system was in bypass and no xray was possible.A mobile c-arm was used to complete the procedure.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.When operating an x-ray tube, heat is generated dependent on the degree of use.To remove the heat, the x-ray tube is equipped with an internal primary cooling.Generated heat is removed via an oil circuit and heat is removed with a secondary water circuit.In the event of a cooling system failure, the system can continue to be operated for a period of time.The failure is announced to the operator by displaying "tube hot, have a break" and the operator can than decide to continue or terminate the procedure.This kind of failure is very rare, however, a field corrective action was reported to the fda via 2240869-07/15/16-0022-c.Parts of the system cooling have been changed and no recurrence has been communicated.

• Brand Name: AXIOM ARTIS ZEEGO
• Type of Device: INTERVENTIONAL, FLUOROSCOPIC, XRAY SYSTEM
• 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: 5952115
• MDR Text Key: 55144287
• Report Number: 2240869-2016-04999
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

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: 10280959
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• 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