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

Model Number	MOSAIQ
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that the gantry angle was different than the one defined in the setup field.Based upon the available information the clinician considers serious mistreatment to the patient.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.Mosaiq worked as designed and intended.The user entry of the setup field data (e.G.Source angle) was not correct, and did not match the user assigned drr (digitally reconstructed radiograph) project which compromised image registration results.This issue is due to abnormal use.The customer is changing their procedure to eliminate initial data entry error by correctly sending set up fields from the treatment planning system (tps).

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale CA 94086
• MDR Report Key: 9260498
• Report Number: 2950347-2019-00019
• Device Sequence Number: 19765908
• Product Code: IYE
• UDI-Device Identifier: 00858164002220
• UDI-Public: 00858164002220
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K183034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other