MAUDE Adverse Event Report: SEDECAL SA SEDECAL; MOBILE X-RAY SYSTEM

Model Number MOVIX 8.0 E+ (DRAGON)

Device Problems Collapse (1099); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

A retrofit kit has been designed for installation on all affected systems.This will prevent the problem from being repeated.

Event Description

This is a mobile x-ray system.There is a combination generator/tubehead/collimator mounted on an articulating arm.During the normal use of the system the weld in the joint, elbow at the top part of the frame was broken.As a result of this the generator assembly fell to the ground.Had there been a patient or user present under the generator assembly when it fell, they likely would have been injured.This unit (b)(4) was produced at sedecal in june 2014.

• Brand Name: SEDECAL
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SEDECAL SA; c/ pelaya, 9 - 13; pol. ind. río de janeiro; algete, madrid 28110 ; SP 28110
• Manufacturer (Section G): SEDECAL SA; c/ pelaya, 9 - 13; pol. ind. río de janeiro; algete, madrid 28110 ; SP 28110
• Manufacturer Contact: maria gomez ; c/ pelaya, 9 - 13; pol. ind. río de janeiro; algete, madrid 28110 ; SP 28110 ; 916280544
• MDR Report Key: 5499509
• MDR Text Key: 40543310
• Report Number: 9617251-2016-00001
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Paramedic
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: MOVIX 8.0 E+ (DRAGON)
• Device Catalogue Number: MOVIX 8.0 E+ (DRAGON)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: 2 YR
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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