MAUDE Adverse Event Report: ELEKTA LTD ELEKTA UNITY; ACCELERATOR, LINEAR, MEDICAL

Model Number	1536549
Medical Device Problem Codes	Computer Software Problem (1112); Failure to Read Input Signal (1581)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an incomplete plan information was imported in mosaiq for (online) mr-linac treatment.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.From the machine logs, it has been determined that the system inhibited safely and terminated the delivery during treatment due to a diaphragm x2 movement.After this termination, the customer tried to re-load fields a few times.All attempts were unsuccessful as the machine had an 'mlc not ok' inhibit that couldn't be cleared without a system reboot.After the customer rebooted the machine, the treatments were continued as normal with the next patient.The machine inhibited safely and was working as designed and intended.

• Brand Name: ELEKTA UNITY
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• Manufacturer (Section G): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• Manufacturer Contact: pms pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 13977005
• Report Number: 9617016-2022-00001
• Device Sequence Number: 12115711
• Product Code: IYE
• UDI-Device Identifier: 05060191071321
• UDI-Public: 05060191071321
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K192482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1536549
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown