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

Device Problems Insufficient Information (3190); Intermittent Communication Failure (4038)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they experienced a facility 1state error part way through a vmat (volume modulated arc therapy) arc, interrupting treatment delivery.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that they experienced a facility 1state error part way through a vmat (volume modulated arc therapy) arc, interrupting treatment delivery.In order to investigate the details of the event and identify the root cause, the system diagnostic data (sdd) logs are required.Unfortunately, it has not been possible retrieve the sdd covering the date of the event as these sdd's are periodically overridden.However, from the description of the event, there is a high probability that the event is similar to "dose runaway".Elekta have identified that it is possible for the displayed delivery mu to rise to the prescribed dose following an abnormal dose diff termination.The integrity software will show an error and report the abnormal termination to the r&v system (mosaiq will display an error).No mistreatment should result providing the customer follow's the instructions in the clinical user manual ("continuing treatment delivery after an abnormal termination): "do not continue unless you record the value of the beam mu display when an abnormal termination of a field occurs.In the r&v system, make sure that the remaining mu to deliver in the partial field is correct before you continue.If you ignore this warning, you can cause clinical mistreatment." a product bulletin (elekta ref: (b)(4)) advising correct actions in case of 'dose runaway' was issued to customers when this issue was recognized.The product bulletin was sent to the customer on 7th january 2019.The user was able to correct the record in mosaiq based on the mu on the backup counter and complete the partial treatment.

• Brand Name: ELEKTA SYNERGY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgaten 18; sweden, 103 9 3; SW 103 93
• 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 -(BL
• MDR Report Key: 17395161
• MDR Text Key: 319750372
• Report Number: 3015232217-2023-00045
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K210500
• 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,Followup
• Report Date: 02/26/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1