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

Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that they believe excess dose is being delivered to the patient before the beam terminates.
Additional Manufacturer Narrative
Due to an administrative error, the initial report was submitted under the wrong manufacturer and therefore an invalid mfr number.No further reports will be sent against this mfr number (3015232217-2024-00029).A corrected report will be submitted under 9617016-2024-00004.

• Brand Name: ELEKTA INFINITY
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 11368 ; SW 11368
• 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: 20188519
• Report Number: 3015232217-2024-00029
• Device Sequence Number: 6793030
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2010
• 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