MAUDE Adverse Event Report: CABLON MEDICAL B.V. THERAVIEW ELECTRONIC PORTAL IMAGING DEVICE; ACCELERATOR, LINEAR, MEDICAL

Model Number 150-55

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Unintended Movement (3026)

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

Event Date 05/16/2018

Event Type  malfunction  

Event Description

Part of the review electronic portal imaging device (epid) imager came out of the bearing rails.The epid has the capability to extend to (and retract from) the iso center position.In this case both bearing stoppers were rotated out of place.This caused the bearings to exit the rails, so the imager dropped out of the rails on the floor.In a similar situation (e.G.Rotated gantry) the possibility exists that the part of the imager can hit the patient.The epid in this situation has had maintenance in (b)(6) 2017, for replacement of the bellows fold up elbow, in which case the screws could have been untightened and fastened again.The epid with these kind of bearing stoppers was placed on the market in 2006.The described situation is the only occurrence of this product problem in the past 12 years.Based on the other systems being investigated, all bearing stoppers were correctly secured, which indicate that recurring of the problem is very unlikely.

• Brand Name: THERAVIEW ELECTRONIC PORTAL IMAGING DEVICE
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): CABLON MEDICAL B.V.; leusden, kleplhoek 11 3833 GZ; NL 3833 GZ
• MDR Report Key: 7605131
• MDR Text Key: 111431922
• Report Number: MW5077866
• Device Sequence Number: 0
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 150-55
• Device Catalogue Number: 150-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other