MAUDE Adverse Event Report: PROTOM INTERNATIONAL HOLDING CORPORATION RADIANCE 330 PROTON BEAM THERAPY SYSTEM

Model Number 330

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

During a virtual simulation (vsim) test of a (b)(6) year old cancer patient that was under general anesthesia, the motion control system (mcs) (a software system) did not permit an operator's command to move the patient positioning robot to a new location.The command to the mcs was made after successful resolution of an alarm condition associated with the radiance 330's gantry control system.The patient was suspended 51 inches off the treatment floor at the time the mcs was not responding to operator commands.The mcs was reset by rebooting the computer its housed on, which successfully resolved the issue associated with the mcs.The patient was subsequently moved to a position in which he could be taken off the patient positioning robot and successfully taken off anesthesia.Completion of the patient's vsim was rescheduled and successfully completed.There were no reports of patient injury, medical intervention, or follow-up care.Protom is reporting the malfunction of the mcs because should a patient under general anesthesia require medical intervention to address a clinical event associated with the anesthesia, the location of the patient may potentially impact the medical treatment.

Manufacturer Narrative

By way of background, prior to delivery of proton radiation treatment plan, a vsim (or "dress rehearsal") is conducted that tests and confirms the patient's respective treatment plan prior to the deployment of the proton radiation.During vsim, patients that require immobilization using anesthesia are subjected to anesthesia, and all clinical workflows (imaging, patient positioning, gantry (scan/dosimetry nozzle) angle) are performed.

• Brand Name: RADIANCE 330 PROTON BEAM THERAPY SYSTEM
• Type of Device: PROTON BEAM THERAPY SYSTEM
• Manufacturer (Section D): PROTOM INTERNATIONAL HOLDING CORPORATION; 500 edgewater drive; suite 522; wakefield MA 01880
• MDR Report Key: 11975698
• MDR Text Key: 281603252
• Report Number: 3013118233-2021-00001
• Device Sequence Number: 1
• Product Code: LHN
• UDI-Device Identifier: 08615520004
• UDI-Public: 08615520004
• Combination Product (y/n): N
• PMA/PMN Number: K191521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 330
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 6 YR