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

Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that positions of the blades between the mosaiq and monaco drrs are not identical.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
Section h6 updated.Section h11 updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The shaped port that was displayed for the first field was the ciao (completely irradiated area outline) of the field.The first field was a stepnshoot type field where collimation changes during a beam-on.By design, the mlc (multileaf collimator) correctly moved to the ciao position for the planned port exposure.Mosaiq did not have any malfunction and was working as designed and intended.Based on the available information there has been no mistreatment.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, SE-11 3 68; SW SE-113 68
• 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: 19729041
• Report Number: 3015232217-2024-00024
• Device Sequence Number: 18190348
• 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): 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): 09/02/2024

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
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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