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

Model Number	MOSAIQ
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 been completed.
Event or Problem Description
The customer reported that they had an issue with a patient who moved the couch due to gripping onto the ends.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.Mosaiq functioned as designed and intended and there was no mistreatment.Once the patient is positioned via the couch to within the geometry defined in mosaiq (which mosaiq does monitor), no other monitoring is available.Centers typically use immobilization devices and video monitoring to ensure that the patient does not move from their intended position.The ability to monitor actual patient movement is not a functionality of mosaiq.

• 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: 8654227
• Report Number: 2950347-2019-00008
• Device Sequence Number: 2600815
• Product Code: IYE
• UDI-Device Identifier: 00858164002220
• UDI-Public: (01)00858164002220(10)2.65.229
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/13/2019

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: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1