MAUDE Adverse Event Report: VISION RT LTD ALIGNRT PLUS

Model Number 6.3.0

Device Problem No Apparent Adverse Event (3189)

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

Event Date 06/10/2021

Event Type  malfunction  

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 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
• Type of Device: ALIGNRT
• Manufacturer (Section D): VISION RT LTD; dove house; arcadia avenue; london, N3 2J U; UK N3 2JU
• Manufacturer (Section G): VISION RT LTD; the crescent; jays close; basingstoke, RG22 4BS; UK RG22 4BS
• Manufacturer Contact: feng ye ; 11340 pembrooke sq, suite 201; waldorf, MD 20603 ; 3017055802
• MDR Report Key: 12156820
• MDR Text Key: 261729697
• Report Number: 3004832819-2021-90001
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 05056190500481
• UDI-Public: 5056190500481
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K203387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6.3.0
• Device Catalogue Number: LA-3CAM-ALRT-ELEKTA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1