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

Model Number MOSAIQ

Device Problems Computer Software Problem (1112); Device Handling Problem (3265)

Patient Problems Unintended Radiation Exposure (4565); Insufficient Information (4580)

Event Type  malfunction  

Event Description

The customer reported that the mu was not matching in mosaiq and monaco tx fields.

Manufacturer Narrative

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

Manufacturer Narrative

Section g2 report source corrected.The initial report stated incorrectly "(b)(4)" in the 'other' field, but this should have stated "(b)(4)" as this mfr report #: 3015232217-2022-00006 is linked with (b)(4).Section h6 updated coding section h10 additional information the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer created and exported a plan to mosaiq.The customer then subsequently modified the plan and proceeded to treat the original plan from mosaiq rather than the modified plan as intended.From the logs there is no record of the modified plan existing in mosaiq when the patient's treatment began, thus even though the plan was changed in the treatment planning system, the changes were never transmitted to the record and verify system.This is considered nonserious, since there was a mismatch between the intended plan and the delivered plan because of abnormal use.Mosaiq did not have any 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: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 14885654
• MDR Text Key: 303701259
• Report Number: 3015232217-2022-00006
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.60
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• 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: 06/03/2022
• 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