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

Device Problems Computer Software Problem (1112); Intermittent Communication Failure (4038)

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

Event Date 07/12/2023

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 disconnections on the sequencer caused the delivered treatment to fail to record in mosaiq.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that disconnections on the sequencer caused the delivered treatment to fail to record in mosaiq.Review of the software logs show that that treatment ended when a "beam mu ch1" error occurred.The machine inhibited safely.Mosaiq received a count of 392.2 mu from the machine as having been delivered which was processed and recorded by mosaiq.Mosaiq worked as designed and intended since it can only record the data that is received from the machine.The machine log review has confirmed that only 120.5 mu of the prescribed 392.2 mu was given by the machine at the time of the error.The customer informed that the remaining dose was given to the patient and that there has been no mistreatment.This recording issue is due to a dose diff termination.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)) was issued to customers.The product bulletin was sent to the customer on 7th january 2019.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgatan 18; box 7593; stockholm, SE-10 3 93; SW SE-103 93
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL,
• MDR Report Key: 17660803
• MDR Text Key: 322376018
• Report Number: 3015232217-2023-00049
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: (01)00858164002282(10)2.81.070
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• 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