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

Model Number H-SERIES

Device Problem Unintended System Motion (1430)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

There was a report of a couch fault, the cck (couch control keypad) could not stop the couch movement.

Manufacturer Narrative

Customer alleged there was a couch fault.When a patient laid down on the couch, the z+ button was used to raise the couch, however, when the z+ button was released, the couch continued to raise to the highest position before stopping.The cck (couch control keypad) buttons would not stop the couch movement.No injury was reported.Investigation is ongoing.

Manufacturer Narrative

The investigation concluded that the cause of the event was due to the hardware.In order to resolve the issue, the cca (couch control assembly) was replaced.No harm was caused to the patient.The risk was determined to be acceptable.

• 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: 16765568
• MDR Text Key: 313541247
• Report Number: 3003873069-2023-00007
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• 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: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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