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

Model Number	1552093
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Adult male needing chemoradiation for glioblastoma; outpatient radiation oncology; unable to radiate- versa treatment machine went down.A wire melted inside the machine, unable to treat patients.Patient was taken from treatment area and asked to wait in waiting area.Vendor service was notified along with physicist.Determined part/repair was needed.Patients were cancelled for remainder of day.Elekta was called, fse notified, fse is on his way from (b)(4).Part is ordered.Manufacturer response for accelerator, linear, medical, elekta medical linear accelerator (per site reporter).Unknown.

• Brand Name: ELEKTA MEDICAL LINEAR ACCELERATOR
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; 400 perimeter center terrace, suite 50; atlanta GA 30346
• MDR Report Key: 16183471
• Report Number: 16183471
• Device Sequence Number: 11334983
• Product Code: IYE
• UDI-Device Identifier: 05060191071574
• UDI-Public: 05060191071574
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/30/2022
• Report Date (Section F): 09/30/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1552093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 09/30/2022