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

Model Number	PROTEUS 235
Medical Device Problem Codes	Imprecision (1307); Failure to Transmit Record (1521); Data Problem (3196)
Health Effect - Clinical Codes	Radiation Overdose (1510); Radiation Underdose (2166)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Event description : on (b)(6) 2020, during the preparation for a treatment, an abort occurred when an abnormal beam was detected.It was not possible to resume manually the partial treatment from dceu (dosimetry counter electronic unit) value, but the tps (treatment planning system) was used to make a single prescribed beam of the normal beam skipping the already delivered spots.Preliminary analysis : the issue is under analysis and is reported preventively.Supplemental report will include analysis of the issue.
Additional Manufacturer Narrative
Evaluation summary is provided in section b5 (describe event or problem).
Event or Problem Description
Event description (from initial report) : on (b)(6) 2020, during the preparation for a treatment, an abort occurred when an abnormal beam was detected.It was not possible to resume manually the partial treatment from dceu (dosimetry counter electronic unit) value, but the tps (treatment planning system) was used to make a single prescribed beam of the normal beam skipping the already delivered spots.Preliminary analysis (from initial report) : the issue is under analysis and is reported preventively.Supplemental report will include analysis of the issue.Evaluation summary (supplemental report): during the analysis of the (b)(6) 2020 event, iba identified an issue with the proton therapy system software versions pts-12.0.0, pts- 12.0.1 and pts-12.0.1.1.When using the iba proton therapy system in combination with an ois in device centric mode, if an irradiation abort occurs resulting in a corrupted or unavailable treatment record, the current pts software does not permit in a straighforward way, the delivery of the aborted beam through the ois.Iba initiated a medical device correction (see recall report iba ref.Pr-115141 - res 86076 / z-2715-2020).Please refer to the recall report for additional details.

• Brand Name: PROTEUSPLUS
• Common Device Name: PROTON THERAPY SYSTEM
• Manufacturer (Section D): IBA (ION BEAM APPLICATIONS); chemin du cyclotron, 3; louvain-la-neuve, 1348 ; BE 1348
• MDR Report Key: 10168195
• Report Number: 3000256071-2020-00003
• Device Sequence Number: 19371147
• Product Code: LHN
• UDI-Device Identifier: 05404013814015
• UDI-Public: (01)05404013814015(11)190507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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
• Operator of Device: Health Professional
• Device Model Number: PROTEUS 235
• Device Catalogue Number: PROTEUS 235
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other