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

Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that offsets were not sent to the accelerator after matching.It was ascertained from the mosaiq logs that during a single fraction course of radiation therapy intended to treat c1 and c2 a use error lead to a geometric miss of the target volume.The patient was placed on the treatment couch and then treated without being positioned in the correct treatment position.The mosaiq couch move assist tools were not used.The location of the treatment cannot be determined from the information provided.The customer has not reported any injury, or adverse sequalae, to the patient.During a course of single fraction radiation therapy a use error has caused the treatment target to be missed, a serious mistreatment by definition.Mosaiq is working as designed.The shifts were not applied as intended and mistreatment occurred due to use error.
Event or Problem Description
The customer reported that offsets were not sent to the accelerator after matching.

• 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: 17697098
• Report Number: 3015232217-2023-00052
• Device Sequence Number: 6632878
• Product Code: IYE
• UDI-Device Identifier: 00858164002336
• UDI-Public: (01)00858164002336(10)2.82.108
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/28/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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