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)
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 monitored volume displayed incorrectly during motion monitoring.
Additional Manufacturer Narrative
The investigation found that in tsm (treatment session manager) motion monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.The clinical impact is when the scaling inconsistency occurs, the position of the delineated contours with respect to the anatomy that is displayed will be erroneous.The magnitude of the error ranges from 0-10% depending on the protocol used and the error increases with distance from the center of the image.Centre of the image is correct and is not impacted by scaling errors.Depending on the anatomy and the geometry of the mass being treated will determine the degree of clinical impact this issue will result in.The issue originates within software of a supplied product within the unity system.During system testing the image scaling issue that impacts only some scanning protocols during motion monitoring workflows were not detected.No patients were mistreated.An important field safety notice (200-01-801-007) was released on (b)(6) 2020 to all customers.A future release of exam cards will correct the issue.An important field safety modification is estimated to be released by april 2021.The elekta recall reference for this action is fca-el-0011.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale, ca CA 94086
• MDR Report Key: 9652138
• Report Number: 2950347-2020-00004
• Device Sequence Number: 2235037
• Product Code: IYE
• UDI-Device Identifier: 00858164002220
• UDI-Public: 00858164002220
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1