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

Model Number	PROTEUS 235
Medical Device Problem Codes	Component Falling (1105); Malposition of Device (2616); Failure to Auto Stop (2938)
Health Effect - Clinical Codes	Abrasion (1689); Hematoma (1884)
Date of Event	05/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remedial action: range shifter insertion process has been changed from a one therapist role to a two therapist role.After range shifter insertion, each therapist independently inspects visually and manually to confirm that the range shifter is in the proper placement.
Event or Problem Description
Description of the event: iba has been informed that on (b)(6) 2018 during the patient alignment phase before treatment, the range shifter was not correctly aligned on the rails.While the gantry was being rotated to the position prescribed for treatment, the range shifter (23 pounds) became dislodged and fell on the head of the patient.Impact of the event on the patient: the patient was sent to the emergency department of the hospital for imaging and assessment for the head trauma.The patient developed a small abrasion with a significant underlying hematoma.The patient was admitted for observation for 24 hours.There was no evidence of skull or cervical-spine fracture; however, the head cup under the patient's head/neck was broken as a result of the blunt impact.The hematoma resolved over the next 3 days.Iba is not aware of any follow-up care required.
Additional Manufacturer Narrative
Evaluation summary is provided in section b5 (describe event or problem).
Event or Problem Description
Description of the event: iba has been informed that on (b)(6) 2018 during the patient alignment phase before treatment, the range shifter was not correctly aligned on the rails.While the gantry was being rotated to the position prescribed for treatment, the range shifter (23 pounds) became dislodged and fell on the head of the patient.Impact of the event on the patient: the patient was sent to the emergency department of the hospital for imaging and assessment for the head trauma.The patient developed a small abrasion with a significant underlying hematoma.The patient was admitted for observation for 24 hours.There was no evidence of skull or cervical-spine fracture; however, the head cup under the patient's head/neck was broken as a result of the blunt impact.The hematoma resolved over the next 3 days.Iba is not aware of any follow-up care required.Evaluation summary: extensive testing identified a deficiency in the snout holder electronic unit: it does only prevent gantry rotation if the accessories locking pins are not activated, whatever the status of the insertion pins, and it is possible to insert a range shifter incorrectly and have the locking pin activated.

• 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: 7532659
• Report Number: 3000256071-2018-00003
• Device Sequence Number: 123741
• Product Code: LHN
• UDI-Device Identifier: 05404013810901
• UDI-Public: (01)05404013810901(11)100126
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/03/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/22/2018
• 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: Hospitalization
• Patient Age: 24 MO