MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY AXIOM ARTIS DBA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 07555357

Device Problems Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 01/31/2017

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

Event Description

It was reported to siemens that a malfunction occurred after use of the axiom artis dba system.Following an examination, the customer reported no image was displayed on the monitor and an explosive sound and odor from the isolation amplifier vga.We are unaware of any impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the report.During the investigation, it was determined that the primary circuit of the power supply of the isolation amplifier otv was defective caused by excessive moisture inside the unit.Moisture traces and deposits have been found inside the housing and on the circuit board.The isolation amplifier otv-vga-v2 has been exchanged and system works as specified.The manufacturer is not considering further actions resulting from this event.

• Brand Name: AXIOM ARTIS DBA
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: 6376151
• MDR Text Key: 69342991
• Report Number: 2240869-2017-00889
• 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,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 07555357
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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