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

Model Number D2RS

Device Problem Unintended System Motion (1430)

Patient Problem No Information (3190)

Event Date 05/29/2018

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): STEPHANIX RADIOLOGICAL SOLUTIONS; 10 rue jean moulin; z.i. du bayon; la ricamarie, 42150 ; FR 42150
• Manufacturer Contact: sandie perret ; 10 rue jean moulin; z.i. du bayon; la ricamarie, 42150 ; FR 42150
• MDR Report Key: 7577669
• MDR Text Key: 110733914
• Report Number: 3006972752-2018-00001
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 03664049000017
• UDI-Public: 03664049000017
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: D2RS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: No
• 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