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

Medical Device Problem Codes	Computer Software Problem (1112); Intermittent Communication Failure (4038)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that disconnections on the sequencer caused the delivered treatment to fail to record in mosaiq.
Additional 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
• Common Device Name: 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
• Report Number: 3015232217-2023-00049
• Device Sequence Number: 15000174
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: (01)00858164002282(10)2.81.070
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K183034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown