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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2023

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 mosaiq did not record the therapy.

Event Description

The customer reported that mosaiq did not record the treatment.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that mosaiq did not record the treatment.The investigation found from the machine and audit logs that the beam started and terminated due to a gantry stop having delivered 222 beam mu and 223 segment mu.These are separate counters on the dose board and as such it is not unusual that they are slightly different.The system will terminate if these counts differ by 3 or more mu.The customer manually recorded the delivered treatment.The prescribed dose was 474.0 mus and there is no further indication of the beam being delivered on that day.For an unknown reason, mosaiq never received data from the linac (machine) indicating that the treatment was happening.Mosaiq can only record data that is received from the machine.Mosiaq did not have a malfunction and was 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: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 16724173
• MDR Text Key: 313124291
• Report Number: 3015232217-2023-00016
• 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: IT
• 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: 07/20/2023

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
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 07/20/2023
• 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