MAUDE Adverse Event Report: ELEKTA INC 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	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the treatment couch coordinates are not captured in mosaiq and are not matching the coordinates that the therapists treated the patients with.
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 b3 updated.Section h6 updated.Section h11 updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.According to the beam records and collected information, mosaiq correctly recorded the couch values for the fields.Truebeam sent the incorrect values to mosaiq due to misconfiguration in the truebeam admin.Mosaiq recorded the data that was sent from the machine.The customer has corrected the misconfiguration for the truebeam machine.Mosaiq did not have any malfunction and is working as designed and intended.Based on the available information, there was no patient mistreatment.Please note that due to an administrative error, the product was initially reported under mosaiq 2.64.210.0001 but this is incorrect and should have been reported under mosaiq 2.83.053 therefore the mfr report number reported against the product is incorrect.A combined report (initial and final) has been submitted under the correct mfr number for this incident capturing all the correct product details (see report 3015232217-2024-0023).

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): ELEKTA INC; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 18864261
• Report Number: 2950347-2024-00002
• Device Sequence Number: 8295396
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.210.0001
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 07/01/2024
• 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