MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPY TREATMENT DELIVERY SYSTEM; MEDICAL LINEAR ACCELERATOR

Model Number	H-SERIES
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There had been smoke from ups2 and the fire department responded.
Additional Manufacturer Narrative
Smoke was emitted from ups2.Fire department was called due to smoke.Fire department removed power cord from cluster ups.The fire department will also investigate this burnt ups.Fse confirmed ups2 is burnt, and it doesn't work.Investigation is in progress.
Additional Manufacturer Narrative
Investigation summary: based on information from the supplier, the analysis found that this type of failure is not common, and a cause could not be determined.Incident failed safely and no one was injured.No further action is required.

• Brand Name: TOMOTHERAPY TREATMENT DELIVERY SYSTEM
• Common Device Name: MEDICAL LINEAR ACCELERATOR
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer (Section G): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1209 deming way; madison, WI 53717 ; 6088242971
• MDR Report Key: 15773626
• Report Number: 3003873069-2022-00017
• Device Sequence Number: 3038760
• Product Code: IYE
• UDI-Device Identifier: M65810182860
• UDI-Public: +M65810182860/16D20161007G
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: H-SERIES
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2016
• 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