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

Model Number	MOSAIQ
Medical Device Problem Codes	Computer Software Problem (1112); Application Network Problem (2879)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the ratm interface initialisation failed.
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 h10 additional information: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was found to be in the interface of the linac which displays the following message to the user: "ratm interface initialization failed".In the issue reported this message was ignored by the user, and the usual treatment/ workflow was attempted.Upon attempting the usual treatment/ workflow, the couch move assistant displayed the device interface error window.The user then restarted the linac, mosaiq sequencer pc, iview pc and the xvi pc.After restarting, the error messages were then not shown, and the treatment commenced.The system inhibits safely by displaying two error messages which shows that the interface has failed: one error message will be displayed in mosaiq and a second error message will be displayed in the couch move assistant.Mosaiq did not have any malfunction and is working as designed and intended.There was no patient mistreatment.

• 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: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 12802178
• Report Number: 3015232217-2021-00003
• Device Sequence Number: 20028218
• Product Code: IYE
• UDI-Device Identifier: 07340201500026
• UDI-Public: 07340201500026
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203172
• 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): 02/08/2022

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: 10/15/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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