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

Model Number ZEE

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 07/25/2018

Event Type  malfunction  

Event Description

Patient placed on table in ir (interventional radiology) room 1: siemens artis biplane room.After starting the procedure the table locked and it couldn't be moved.Lost ability to use tableside controls.Manufacturer response for ir angiography suite, axiom artis (per site reporter) : pending.

• Brand Name: AXIOM ARTIS
• Type of Device: STATIONARY ANGIOGRAPHIC X-RAY SYSTEM, DIGITAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC; 40 liberty boulevard mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 7776261
• MDR Text Key: 116886648
• Report Number: 7776261
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2018

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: Other
• Device Model Number: ZEE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2018
• Device Age: 12 YR
• Event Location: Other
• Date Report to Manufacturer: 08/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1