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

Model Number AXIOM ARTIS BI-PLANE

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 11/15/2017

Event Type  malfunction  

Event Description

Patient brought into ir room for tumor embolization.After access, error was noted saying no x-ray available.Room was rebooted but unable to get room working.

• Brand Name: AXIOM ARTIS
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 40 liberty boulevard; mail code: 65-1a; malvern PA 19355
• MDR Report Key: 7178538
• MDR Text Key: 96873336
• Report Number: 7178538
• 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: Patient
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AXIOM ARTIS BI-PLANE
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2017
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Weight: 53