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

Model Number PROTEUS 235

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Malposition of Device (2616); Failure to Auto Stop (2938)

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

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary is provided.

Event Description

Description of the event: iba has been informed that, on (b)(6) 2017, during a patient treatment, the range shifter was not correctly aligned on the rails.A range shifter is used in pencil beam scanning to shift the dose distribution in the targeted area in the patient.Treatment fields were delivered with a slightly angled range shifter.After the delivery of the treatment, while the gantry was at 340°, the patient hit the range shifter while getting sitted.The range shifter (23 pounds) then fell out and grazed the patient face.Impact of the event on the patient: the patient was sent to the emergency department of the hospital for evaluation.The patient was released with no injuries.The hospital evaluated the impact of the slightly angled range shifter on beam properties in treatment field to less than 1 mm in water-equivalent-thickness change for the treatment field, therefore well within their margin used in treatment planning.Iba is proactively reporting this event due to the heavy weight of the range shifter and significant impact it could have if there was a new occurrence.Evaluation summary: investigation demonstrated that the range shifter can be inserted with only the upper rail in the guide, the lower rail resting just outside the guide (see attachment).With this configuration, the locking pin will lock the range shifter into place and the insertion pins will also be pushed in (see attachments).However, with minimal outward pressure, the range shifter can be pulled out of the holder and fall.

• Brand Name: PROTEUSPLUS
• 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, 1348 ; BE 1348 ; 10 203787
• MDR Report Key: 6961204
• MDR Text Key: 90652519
• Report Number: 3000256071-2017-00003
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other