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

Device Problem Computer Software Problem (1112)

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

Event Date 12/04/2023

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 a network disconnection during irradiation resulting in the field not being recorded in mosaiq.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.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.The customer has entered a manual recording.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; hagaplan 4; box 7593; stockholm, SE-11 3 68; SW SE-113 68
• 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: 18417218
• MDR Text Key: 331588615
• Report Number: 3015232217-2023-00073
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: (01)00858164002282(10)2.81.070
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/05/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• 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