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U.S. Department of Health and Human Services

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

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IBA (ION BEAM APPLICATIONS) PROTEUSPLUS PROTON THERAPY SYSTEM Back to Search Results
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.

 
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Brand NamePROTEUSPLUS
Type of DevicePROTON 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 Key7482297
MDR Text Key107728693
Report Number3000256071-2018-00001
Device Sequence Number1
Product Code LHN
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK082416
Number of Events Reported1
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 Received05/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPROTEUS235
Device Catalogue NumberPROTEUS235
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 Received04/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/19/2018
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
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