MAUDE Adverse Event Report: IBA (ION BEAM APPLICATIONS) PROTEUSONE; PROTON THERAPY SYSTEM

Model Number PROTEUS 235

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred because of the failure of rod end bearings (ball joint heads).The broken ball joint heads were immediately replaced on site.

Event Description

The proteusone treatment rooms are equipped with a gantry rolling floor that enables the clinician to enter the patient enclosure to help patient positioning on the couch.This rolling floor is moving in conjunction with the gantry.During cone beam computed tomography acquisition, the gantry rolling floor detached from the nozzle.As a consequence, the gantry rolling floor slipped under its own weight through the rail.No one was standing on the gantry rolling floor during the gantry rotation as specified in the clinical user guide.No injury was reported.

• Brand Name: PROTEUSONE
• Type of Device: PROTON THERAPY SYSTEM
• Manufacturer (Section D): IBA (ION BEAM APPLICATIONS); chemin du cyclotron 3; louvain-la-neuve, 1348 ; BE 1348
• Manufacturer Contact: sylviane berger ; chemin du cyclotron 3; louvain-la-neuve,
• MDR Report Key: 8099710
• MDR Text Key: 129332070
• Report Number: 3000256071-2018-00004
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/16/2018

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: Health Professional
• Device Model Number: PROTEUS 235
• Device Catalogue Number: PROTEUS 235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other