MAUDE Adverse Event Report: ELEKTA LTD VERSA HD; ACCELERATOR, LINEAR, MEDICAL

Device Problem Low impedance (2285)

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

Event Date 09/17/2023

Event Type  malfunction  

Event Description

On sunday september 17th the in-house hospital team had been running experimental clinical beams with the versa hd linac (outside of clinical hours & not treating patients).Having experienced repeated inhibits of low dose rate during the day, at 6:40 p.M the dose rate of the beam dropped from 570 to 430.The hospital team started investigating the low dose fault.Elekta received a call from the hospital engineer requesting assistance in the repair.The versa hd linac was running in service mode with interlocks overridden.The hospital engineers when joined by elekta service engineer at 8:10 pm, they reported no obvious abnormalities when viewing the relevant parameters.The machine was shut down and restarted at about 8:20 p.M.(the versa hd was operating in ctrl t interlock group & service mode with all interlocks overridden).The machine still reported the same fault, low dose rate.The elekta engineer followed by the hospital engineer went to the spare parts room on the 2nd floor to obtain measurement equipment in preparation for performing measurement tests on the versa hd, about 2-3 minutes later back to the operation room, ht psu ot and other faults, were displayed, resetting the equipment did not remove the inhibit.The equipment was shut down and the engineers prepared to enter the computer room to troubleshoot the fault, entering the computer room found that there was obvious smoke.

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

• Brand Name: VERSA HD
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• 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: 17955710
• MDR Text Key: 327029129
• Report Number: 9617016-2023-00002
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 05060191071017
• UDI-Public: 05060191071017
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2018
• 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