MAUDE Adverse Event Report: ELEKTA LTD XVI; ACCELERATOR, LINEAR, MEDICAL

Model Number 1502322

Device Problems Computer Software Problem (1112); Data Problem (3196)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer has reported a mismatch between the table shift values sent from xvi to cma and the values which are stored in xvi and then sent to the localisation trend review and displayed in the image review workspace.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The manufacturers investigation found that the user encountered a mismatch between the table shift values sent from xvi when the user is trying to accept a table shift of zero incorrectly, i.E.No table shift is required.If no shift is required then the 'convert to correction' button is not enabled.In this case, the user then entered a 'manual correction' mode which then enables the 'convert to correction' button.If this button is then pressed, incorrect shift information is used and the image is no longer correctly aligned/registered.This can be avoided by use of an improved workflow.When an empty or zero correction needs to be saved, one can enter zeros in all three available edit boxes after pressing the "edit or enter correction" button and then press "accept" to have both a zero correction and a proper registration for trending analysis.An alternative workflow was provided to the customer who is satisfied with the proposed solution.Software will be updated to improve the workflow.The software is proposed to be fixed in the next xvi release.

• Brand Name: XVI
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• MDR Report Key: 7381021
• MDR Text Key: 104046033
• Report Number: 9617016-2018-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K131965
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1502322
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1