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	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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 quick notes display still shows status as, "voided notes as active.".
Additional Manufacturer Narrative
H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a defect in the product.It was ascertained that quick notes can be voided and can be moved to the "all voided notes".However, the voided notes continue to appear in the quick notes view.The user can add information to a free text data field which can be modified.However, mosaiq does not make any clinical decisions or take any direct actions based on the quick notes data.This issue would not result in patient harm and is not a safety issue.A software release to correct this issue is due to be released in mosaiq version 3.0 sp1.

• 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: 10911007
• Report Number: 2950347-2020-00041
• Device Sequence Number: 3216876
• Product Code: IYE
• UDI-Device Identifier: 00858164002336
• UDI-Public: 00858164002336
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1