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

Model Number	MOSAIQ
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that mosaiq crashed during a vmat treatment execution.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
H2 updated h3 updated.H6 updated.H10 updated.An investigation was attempted by conducting an evaluation of the product and the reported information.The customer was contacted several times for data required to investigate the reported problem.All attempts to obtain additional information were unsuccessful.Therefore it has not been possible to determine if a malfunction occurred with the product.

• 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: 17141608
• Report Number: 3015232217-2023-00036
• Device Sequence Number: 1932191
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: (01)00858164002282(10)2.81.070
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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
• Device Model Number: MOSAIQ
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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