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

Model Number MOSAIQ

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

The customer reported that the machine went down during treatment of a patient.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 284034305
• Report Number: 3015232217-2021-00004
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 07340201500026
• UDI-Public: 07340201500026
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1