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 10/23/2022

Event Type  malfunction  

Event Description

The customer reported that mosaiq missing dose in the treatment following power outage.

Manufacturer Narrative

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

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The machine experienced a "beam mu ch1 error".There are two dose channels, channel 1 and channel 2.Each channel has a beam mu count and a segment mu count.The beam mu counts the total for the beam and the segment mu counts each segment.These are separate independent counters on the dose card.The reason for the two channels and the independent counts is to have redundancy should one of the counts fail.So as the beam deliverers the two channels should read the same value.If they are different by more than the tolerance the beam will terminate with a "beam mu ch1 error".The termination reason will be displayed on the linac screen and reported via icom that a "beam mu ch1" error had occurred.This data would also be recorded in the log files.When this occurs the customer should check the number of mu's shown on the linac counter because at this point the treatment chart should be corrected to the number of mu's that were actually delivered.With this case mosaiq received a count of 421.4 mu from the machine as having been delivered and this was recorded by mosaiq.The customer informed that only 70 mu showed on the machine's display counter.This information cannot be verified as the machine logs that covered the date of the incident are not available from the customer site.Investigation into this case cannot be concluded due to insufficient information and the cause cannot be established.

• 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: 15824671
• MDR Text Key: 303933840
• Report Number: 3015232217-2022-00019
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.214
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• 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: 10/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• 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