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

Model Number 151341

Device Problems Nonstandard Device (1420); Unintended System Motion (1430)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

The customer reported ratm unexpected table move.Patient possibly mistreated.

Manufacturer Narrative

The manufacturer has investigated this case and the log files appear to indicate that an actual mistreatment occurred.The fact that the lateral position is identical to the previous scan, when taken in conjunction with the theraview records, would appear to indicate that the xvi table lateral position was frozen ie the lateral position was not being updated as the table was moved.If we assume that the theraview lateral position of 0.14 was correct, then treatment occurred approx 6.5cm away from the correct position.Field safety corrective action ((b)(4)) was released (b)(4) 2014 for distribution to customers.

• 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: 3865846
• MDR Text Key: 4462273
• Report Number: 9617016-2014-00009
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 151341
• Other Device ID Number: 4.5.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Other