MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC AXIOM ARTIS Q; SYSTEM, X-RAY, ANGIOGRAPHIC

Device Problems Fire (1245); Smoking (1585); Arcing (2583)

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

Event Date 02/10/2016

Event Type  Injury  

Event Description

While performing sir mapping on a patient, the fluoroscopy stopped working.It was shut down and on restart, electrical arcs, flames and smoke were noted.Manufacturer response for imaging, axiom artis q (per site reporter): sales reps from siemens present during incident and aware of issue.

• Brand Name: AXIOM ARTIS Q
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 5480269
• MDR Text Key: 39674014
• Report Number: 5480269
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Other Device ID Number: GIGALIX125/30/40/90
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 76 YR
• Patient Weight: 106