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

Model Number H-SERIES

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

There had been smoke from ups2 and the fire department responded.

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.

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
• Type of Device: 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
• MDR Text Key: 307883650
• Report Number: 3003873069-2022-00017
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: M65810182860
• UDI-Public: +M65810182860/16D20161007G
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H-SERIES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1