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

Model Number MOSAIQ

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 03/17/2023

Event Type  malfunction  

Event Description

The customer reported that no partial beam has been created in mosaiq.

Manufacturer Narrative

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

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that no partial beam has been created 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 513.0 mu from the machine as having been delivered which was processed and recorded by mosaiq.The machine log was reviewed and confirmed that only 471.3 mu of the prescribed 513.0 mus was treated.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; crawely, west sussex RH10 -9BL
• MDR Report Key: 16741384
• MDR Text Key: 313303601
• Report Number: 3015232217-2023-00021
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.040
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

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
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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