MAUDE Adverse Event Report: VISION RT LTD ALIGNRT PLUS

Model Number	6.3.0
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident was reported to the manufacturer as a beam hold failure.Investigation of the logs pertaining to the incident show that alignrt was set up with a 2-second delay to holding the beam.Accordingly, alignrt started a 2-second countdown to beam hold when the patient moved out of pre-defined tolerances.The operator was alerted by alignrt to the patient moving out of tolerance and the operator manually held the beam within the countdown timeframe.Alignrt performed as intended and remote inspection shows that it continues to perform to specification.No harm was reported to the patient or user.The incident is not reportable as there was no adverse event (harm) or potential to cause an adverse event if the incident occurred again.However, the manufacturer decided to file a report due to the nature of the initial report from the user facility.
Event or Problem Description
A patient was undergoing radiotherapy on an elekta synergy linear accelerator.Alignrt was set up to automatically hold the beam of the linac if the patient moved out of pre-defined tolerances for more than two (2) seconds.The patient's roll delta moved out of tolerance.Alignrt started the 2 second countdown to beam hold.The deltas showed on the screen and the operator manually held the beam after one (1) second.The operator reported the manual intervention to the manufacturer as a beam hold failure, as they had expected alignrt to automatically hold the beam after one (1) second.The same centre reported a recurrence of the incident on a different patient the next day ((b)(6) 2021) and a previous incident the month before (not previously reported to the manufacturer).There was no harm reported to the patient or user.

• Brand Name: ALIGNRT PLUS
• Common Device Name: ALIGNRT
• Manufacturer (Section D): VISION RT LTD; dove house; arcadia avenue; london, N3 2J U; UK N3 2JU
• MDR Report Key: 12156820
• Report Number: 3004832819-2021-90001
• Device Sequence Number: 3769309
• Product Code: IYE
• UDI-Device Identifier: 05056190500481
• UDI-Public: 5056190500481
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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: 6.3.0
• Device Catalogue Number: LA-3CAM-ALRT-ELEKTA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1