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 12/20/2023

Event Type  malfunction  

Event Description

The customer reported a table lateral error/ unexpected lateral shift.

Manufacturer Narrative

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

Manufacturer Narrative

Section d4 udi corrected.Section h6 updated.Section h11 updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.Based on the machine log and treatment history report, the couch was positioned at vrt=-17.5, ang=0, lat=0.2, lng=57.3 when the first field was treated.A table lateral error occurred after the prescribed 203.7 mu and the system inhibited and displayed a warning to the user.The second field was fully treated with 295.9 mu with the table at vrt=-17.6, ang=0, lat=0.1, lng=57.4.There is no evidence of patient mistreatment that resulted from the table positioning error.This issue was caused by potentiometers being out of calibration.The tolerances of each couch axis are vrt=0 (tol=0.5), ang=0 (tol=2.0), lat=0 (tol=0.5), lng=0 (tol=0.5).If the machine goes beyond these tolerances, then an inhibit will be displayed as was the case in this instance.Mosaiq did not have any malfunction and is working as designed and intended.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, SE-11 3 68; SW SE-113 68
• 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: 18756784
• MDR Text Key: 336763484
• Report Number: 3015232217-2024-00008
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.040
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K183034
• 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: 05/24/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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