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 09/06/2023

Event Type  malfunction  

Event Description

The customer reported that only half the meterset units (mu) delivered was registered.

Manufacturer Narrative

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

Manufacturer Narrative

H2 updated.H6 updated.H10 updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that only half the meterset units (mu) delivered were registered.Elekta's investigation found that there was an error in the dicom data mosaiq received from the machine (3rd party product - proton therapy) which displayed the following warning message to the user "mismatch number of spot scan positions to size of scan spot position map in control point 6 in beam 02:tx".There was an interruption of the treatment whereby the user needed to manually record the delivered dose.Whilst the user was attempting to manually record the number of monitor units in mosaiq, the number of "spots" entered by the user did not match the monitor units (mu's) that was received from the machine (3rd party product).The user then attempted to continue with the treatment, however as the number of spots recorded did not match the mu's recorded, reconciliation by the user was required.Whilst the user was attempting reconciliation in mosaiq, either the user's specified number of spots did not match up with the mu recorded or the programs proposed number of spots did not match up with the mu's recorded (which was wildly incorrect).Mosaiq displayed the following error message to the user, "to use 50 spots, specify 0.8 meterset delivered", if the customer knows that the mu's is accurate and the number of spots is not, the user should just specify the meterset.The user should either enter 0 spots to let mosaiq calculate it, or use the field meterset method for completion calculation.This was use abnormal use and the customer has been provided with additional documentation on how to manually record the field when the mu is known so mosaiq will calculate the spots.There has been no patient mistreatment.Mosaiq did not have any malfunction and 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: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 17875134
• MDR Text Key: 324961301
• Report Number: 3015232217-2023-00063
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.278
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K141572
• 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: 12/18/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 12/18/2023
• 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