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

Model Number	MOSAIQ
Medical Device Problem Codes	Computer Software Problem (1112); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
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 machine went down during treatment of a patient.
Event or Problem Description
The customer reported that the machine went down during the treatment of a patient.The customer tried to close out the patient from the machine, but they were unable to, and manually recorded the dose treated.Once the machine was back up and running, the patient information was still showing, and the customer had not actually closed out the patient as they originally thought.When the customer treated the patient, the partial treatment was recorded.The customer attempted to zero out the manually recorded mu/dose which corrected the dose recording but did not fix the mu left to be treated.When the "treat" button is clicked on to send the fields to the machine, an error pops-up.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and reported information.If the user attempts to manually record a treatment session for the same allocation as another treatment session, it is possible for two treatments to be recorded for the same day.When this occurs, the patient's chart will highlight to the user (in red) that the patient was prescribed twice the dose; once by the machine and the second time by the manual recording.This is functionality that is required for physicians to be able to adjust records and to correct any interruptions in communication.This issue is detectable by the user.The user was notified of the additional dose being recorded by the system and chose to proceed.The user was able to correct the recording and there was no patient mistreatment.Mosaiq did not have any malfunction and is working as designed and intended.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgatan 18; box 7593; stockholm, SE-10 3 93; SW SE-103 93
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 12802299
• Report Number: 3015232217-2021-00004
• Device Sequence Number: 14846578
• Product Code: IYE
• UDI-Device Identifier: 07340201500026
• UDI-Public: 07340201500026
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K203172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 02/01/2022
• 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