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 03/08/2023

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 that during treatment there was a beam timer error.The bmdm was reset and the modality became unknown.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that during treatment there was a beam timer error.The bmdm (beam mu dose/display module) was reset and the modality became unknown.It was ascertained from the mosaiq log files that the treatment delivery was interrupted by beam timer errors.At this point 458.2 mus of the prescribed 687.7 mus was delivered.The customer informed that the user reset the bmdm, as they wanted to resume treatment, but the actual modality was not registering.The remaining mus were delivered at the end of the day (last fraction) and there was no mistreatment.The cause of why the actual value was displayed as 'none' for modality on the machine (and showed as 'unknown' in mosaiq as a results of this) whilst the prescribed values were set cannot be established due to the sdd logs no longer being available for investigation from the customer site.The customer has been advised to retain the sdd logs and provide them to elekta if this error reoccurs.

• 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: 16688271
• MDR Text Key: 312760798
• Report Number: 3015232217-2023-00015
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002336
• UDI-Public: (01)00858164002336(10)2.82.108
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2020
• 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