MAUDE Adverse Event Report: IBA (ION BEAM APPLICATIONS) ADAPTINSIGHT; I2C

Model Number	I2C
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Iba has been informed that on (b)(6) 2018 during daily checks performed on the system, an unexpected shift in position of a phantom installed on the patient positioning system was observed.The processing unit was power cycled and adapt insight workstation was restarted.Afterwards, the same test as above was performed and this time the phantom was still aligned properly.No patient was involved.
Additional Manufacturer Narrative
Evaluation summary is provided in event.
Event or Problem Description
Iba has been informed that on october 31, 2018 during daily checks performed on the system, an unexpected shift in position of a phantom installed on the patient positioning system was observed.The processing unit was powercycled and adaptinsight workstation was restarted.Afterwards, the same test as above was performed and this time the phantom was still aligned properly.No patient was involved.Evaluation summary: analysis of the event identified a white band on the side of one third party flat panel as the cause of the shift in the phantom position.Third party supplier has been informed of this issue and confirmed that they had not been notified of such a defect previously.As the issue is not reproducible, it is currently not possible to conduct further analysis of this one-time event with third party flat panel.The panel will be monitored in order to collect additional data in case of a new occurrence.

• Brand Name: ADAPTINSIGHT
• Common Device Name: I2C
• Manufacturer (Section D): IBA (ION BEAM APPLICATIONS); chemin du cyclotron 3; louvain-la-neuve, 01348 ; BE 01348
• MDR Report Key: 8120233
• Report Number: 3000256071-2018-00005
• Device Sequence Number: 1579731
• Product Code: LHN
• UDI-Device Identifier: 05404013830923
• UDI-Public: (01)05404013830923(11)140619
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: I2C
• Device Catalogue Number: I2C
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1