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

Model Number 15081

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

No adverse event occurred.The customer reported that m1 was applying a lateral shift when performing a cone beam ct.What was observed was that the absolute value of the couch lateral on xvi is different from the console.On the xvi it is saying -0.5 while on the linac it is saying +4.0 that is a discrepancy of ~4.5cm.When the shift was accepted, the final couch position was -0.4.

Manufacturer Narrative

The manufacturer's investigation has concluded that table re-subscription meant that stale data was used for the table position.The error can be seen but only if your are comparing between the screens of xvi and the linac, and even then the tolerance markers are behaving as expected on each system, it is just the actual values that appear different and the fact that xvi says it is in tolerance and the linac displaying it is not.An ifsn is currently being drafted to be released to users and there is a current plan to upgrade 4.5.1 customer sites to 5.0.2.

• 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
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 3721328
• MDR Text Key: 20857921
• Report Number: 9617016-2014-00007
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/02/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 15081
• Other Device ID Number: 4.5.1.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 04/02/2014
• 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