MAUDE Adverse Event Report: STEPHANIX RADIOLOGICAL SOLUTIONS STEPHANIX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	D2RS
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our r&d department is working on this issue.We think we will be able to propose a solution in the end of next month (end of (b)(6)).
Event or Problem Description
The table was in vertical position, the operator wanted to move the table with joystick, but when he released the command, the table kept moving until he used the emergency stop.Thus we have uncommanded table movement.

• Brand Name: STEPHANIX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): STEPHANIX RADIOLOGICAL SOLUTIONS; 10 rue jean moulin; z.i du bayon; la ricamarie rhone-alpes, 42150 ; FR 42150
• MDR Report Key: 7577669
• Report Number: 3006972752-2018-00001
• Device Sequence Number: 1698185
• Product Code: JAA
• UDI-Device Identifier: 03664049000017
• UDI-Public: 03664049000017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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
• Operator of Device: No Information
• Device Model Number: D2RS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1