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

Model Number PROTEUS235

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Human Factors Issue (2948)

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

Event Date 03/26/2018

Event Type  malfunction  

Event Description

On (b)(4) 2018, iba was made aware of a potential event in the clinical workflow of one customer in (b)(6), resulting in the correction vector not being applied before patient treatment.This event occurred after an upgrade of the hand pendant from wired to wireless at end of (b)(6) 2018.A number of patients has potentially received their treatment at a wrong position.The client and iba are currently investigating the possible impact on the treatment of each individual patient for the period in question.Since (b)(6) 2018, the client has adapted the clinical workflow to ensure that the correction vector is applied.

Event Description

Description of the event (from initial report): on april 19 , 2018, iba was made aware of a potential event in the clinical workflow of one customer in sweden, resulting in the correction vector not being applied before patient treatment.This event occurred after an upgrade of the hand pendant from wired to wireless at end of march 2018.A number of patients has potentially received their treatment at a wrong position.The client and iba are currently investigating the possible impact on the treatment of each individual patient for the period in question.Since april 19, 2018, the client has adapted the clinical workflow to ensure that the correction vector is applied.Patient impact analysis (supplemental report): the customer and iba are investigating the possible impact on each patient treated during this time period.The analysis to date suggests that a deviation occurred on 50 different occasions and involved 20 different patients who could have been affected.Initially, it was believed that one patient was at risk for adverse consequences.Upon further analysis with the involved physicians, the discrepancy was determined to be within the normal clinical range of treatment fields.There was no significant clinical impact on any patient treatment.Evaluation summary (supplemental report): during the analysis of the event, iba identified a weakness in the software when used in combination with a wireless hand-pendant.Iba initiated a recall - medical device correction (see recall report fda ref.Res (b)(4)).See the recall report for additional details.

• 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
• MDR Report Key: 7482297
• MDR Text Key: 107728693
• Report Number: 3000256071-2018-00001
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• PMA/PMN Number: K082416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROTEUS235
• Device Catalogue Number: PROTEUS235
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other