MAUDE Adverse Event Report: STEPHANIX STEPHANIX; SYSTEM, X-RAY, FLUOROSCOPIC

Model Number D2RS

Device Problems Component Falling (1105); Mechanical Problem (1384); Unintended Collision (1429)

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

Event Type  malfunction  

Event Description

We have detected a potential risk in our d2rs devices, that could lead to the sliding of the column support carriage to its end of travel and could harm a patient, a user, or a third party.The main risk factor of this event could be an excessive tension of the column support carriage drive chain associated with other simultaneous factors which make this risk really unlikely.Although this incident has never occurred, a safety action is initiated in order to completely eliminate this potential risk and to ensure the safety of patients, users and third parties.

Manufacturer Narrative

We have concluded that the installation of spring washers improves the management of tension of the carriage train.Affected units are being corrected in the field and the correction has already been implemented in the factory.

• Brand Name: STEPHANIX
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC
• Manufacturer (Section D): STEPHANIX; 10 rue jean moulin; la ricamarie 4215 0; FR 42150
• Manufacturer Contact: 10 rue jean moulin; la ricamarie 42150 ; 477478160
• MDR Report Key: 4827777
• MDR Text Key: 5915142
• Report Number: 3006972752-2015-00001
• Device Sequence Number: 1
• Product Code: JAA
• 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: Other
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 06/02/2015

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: D2RS
• Device Catalogue Number: D2RS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1