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

Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the vault does not have enough protection for 10mv beam.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
H6 updated.H11 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that the vault does not have enough protection for 10mv beam.The investigation found that during installation the vault shielding requirements were not met for 10mv xray beams.It was ascertained that during the original installation acceptance testing, which included a site radiation measurement, identified the shielding deficiency.Actions taken during the original acceptance prevented 10mv xray beam from clinical operation.An elekta service visit identified that the 10mv xray beam option in service mode could still be operated and the service engineer updated the licence key to remove completely the 10mv operation.This issue only occurs in service mode and not in clinical mode, therefore no patient mistreatment can occur.This issue is detectable prior to use.The original acceptance measurements detected the shielding issue as part of the installation process.The room specifications are the responsibility of the hospital appointed radiation protection advisor.

• Brand Name: ELEKTA INFINITY
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer (Section G): ELEKTA LIMITED; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 18418214
• Report Number: 9617016-2023-00004
• Device Sequence Number: 20534958
• Product Code: IYE
• UDI-Device Identifier: 05060191071512
• UDI-Public: 05060191071512
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K210500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2019
• 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