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 10/03/2022

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 an issue with mus not being recorded.

Manufacturer Narrative

H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported as issue with mosaiq not recording the delivered dosage (mus - monitor units) that the patient received during treatment.Investigation of the mosaiq logs found that the machine was set for the patient to receive a total prescription of 339 mus formed of six fields.The treatment was inhibited safely due to a "leaves not ready x1" machine fault after 158 mus of the 339 mus were given to the patient.At this point three of the fields had been fully treated as prescribed (102r, 104r and 106r).The machine fault affected how the 158 mus was processed for recording.All 158 mus were recorded to only one of the fields (102r) and not to the three fields.This prompted the 'monitor units delivered is greater than the mu prescribed' message to be displayed.The 158 mus should have been allocated to reflect that field 102r was fully treated with 51.2 mu, field 106r was fully treated with 11.9 mu, and field 104r was fully treated with 94.9 mu.Fields 101r, 103r, 105r were not treated in this session.When this issue occurs, it is obvious to the user that the treatment was not recorded (or recorded incorrectly).With the data from the machine log, the user (with help from our product support) would be able to verify the actual treatment and the user could record manually what was treated or correct any incomplete/incorrect treatment.This issue would not lead to serious injury.Based on the available information there has been no mistreatment.Mosaiq worked 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: 16111026
• MDR Text Key: 307511442
• Report Number: 3015232217-2023-00002
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.210.0001
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K141572
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• 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: 12/09/2022
• 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