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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

The customer reported that it was possible to complete an off-line treatment without entering a password in mosaiq.This occured following communication failure, when the given dose was not captured and the treatment was recorded manually.

Manufacturer Narrative

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

Manufacturer Narrative

H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that it was possible to complete an off-line treatment without entering a password in mosaiq.This occurred following communication failure, when the given dose was not captured and the treatment was recorded manually.From the mosaiq logs the investigation found that the issue of the lost connection was due to a workstation lock-up.When this happens the prescribed treatment is delivered, as intended; however, the sequencer application is no longer in operation to receive the treatment verification and record the provided treatment information.Review of the record, user messages, and/or in operation of the software will make clear to the user that the provided treatment has not been recorded.As the treatment is delivered as prescribed, no serious injury would be foreseeable if the event were to recur.When the communication was re-established and the patient's treatment calendar was accessed the user was presented with a "treatment delivery not complete" warning message.The user acknowledged this message, however user did not perform a manual recording at that time.The user entered a manually recording two days later, in completing this process they did not receive the "treatment delivery not complete" message requiring a password acknowledgement again as this had previously been acknowledged.Mosaiq worked as designed and intended.Based on available information there was no mistreatment.

• 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: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 16831945
• MDR Text Key: 314176569
• Report Number: 3015232217-2023-00026
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.053
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

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
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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