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

Device Problem Computer Software Problem (1112)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

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 a cma to site setup data mismatch.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a defect in the product.It was ascertained that in the localisation trend review, it is possible to end up with two different "current" shift values for the same site.If the user were to randomly pick the incorrect shift, there could be a larger than accounted for discrepancy between the planned and delivered dose.This could be associated with a non-negligible degradation of plan quality.If the error was not detected it could result in non-serious injury.For the problem to occur, the localisation trend review (ltr) window would have to be opened concurrently for the same patient by two separate users.In addition the users would have to perform localisation edits for the same prescription.Ltr is not connected to cma (couch move assist) and therefore would not be used to alter current treatment, but could influence upcoming treatments.However, the patient would be imaged before any subsequent treatments and any discrepancies would be detected and investigated.Also, only one "current" shift value should be returned.When two "current" values are returned, this would prompt investigation by the user.The probability of this occurring would be implausible.No patients were mistreated.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale CA 94086
• MDR Report Key: 9502410
• MDR Text Key: 188493265
• Report Number: 2950347-2019-00026
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1