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 11/29/2022

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

H6 updated.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 in a treatment plan that was delivered with composite field sequencing, a network error occurred (after the first two fields were delivered), on a move only segment, causing a communication error between the citrix server and sequencer.The network error resulted in all delivered monitor units being incorrectly recorded for the first field and zero monitor units being recorded for the second field (recording issue).The user received a warning that more monitor units (mus) than expected were delivered to the first field.In addition, a second warning was presented informing the user that a network error had occurred and any treatment recordings should be verified.The user would also receive dose warnings as well when selecting to treat the second field and the remainder of the fields in the session.Despite the warnings presented by mosaiq the user, re-selected the dosage for the field that had recorded zero monitor units.Based upon the information available this additional dosage to the patient has been assessed by elekta physics as insignificant.The root cause for this issue was determined to be use error.

• 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: 16111028
• MDR Text Key: 307511506
• Report Number: 3015232217-2023-00001
• 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: 06/06/2023

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