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

Model Number 07413078

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

The event is currently under investigation and a root cause has not yet been determined.A supplement report will be filed at the close of the investigation.This event occurred in the (b)(6): (b)(6).

Event Description

It was reported to siemens that during a procedure on the axiom artis dtc system, the user noticed a burning smell and smoke coming from the system cabinets located in the technical room.The technical room smoke sensor alarmed and the user switched off the power to the system.The procedure was interrupted and was continued on an alternative system.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 investigation of the affected component did show damage of the two mkt capacitors at the input circuit.The power supply is designed for a averaged lifetime of 10 years and the exchange rate of this component in the specified life time is very low (< 0,3 % in 2015).The system and the affected component exceeded the specified life time and was determined as the root cause.The system has been repaired and no reoccurrence has not been reported.

• Brand Name: AXIOM ARTIS DTC
• Type of Device: INTERVENTIONAL, FLUORSCOPIC 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: 5614412
• MDR Text Key: 44583538
• Report Number: 2240869-2016-01476
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

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: 07413078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2006
• 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