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.

• 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
• 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
• Reporter Country Code: SW
• PMA/PMN Number: K082416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL,U
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 04/19/2018
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 05/03/2018 Patient Sequence Number: 1