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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Patient Problem/Medical Problem (2688); Unintended Radiation Exposure (4565)

Event Date 04/08/2020

Event Type  Injury  

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 problem with their response box.The response box is not holding the beam as it should.

Manufacturer Narrative

Section g2 report source corrected.Health profesional unticked.Section g3 'date received by manufacturer' corrected to 13th may 2020.The investigation was completed by conducting a thorough evaluation of the product and the reported information.It was found that the machine is working as designed and intended.There are several interlocks and safety checks that are carried out on a continuous basis that monitor the status of the relays, controls, communication and software at all times.A failure or malfunction of any one signal would result in a change to the status leds and a message being shown on the control software.This would interrupt or terminate the beam and prevent treatment being delivered.The mistreatment to the patient was assessed to be minor and no remedial treatment was required.

• Brand Name: ELEKTA INFINITY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 10216974
• MDR Text Key: 197750587
• Report Number: 9617016-2020-00004
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00506019107017
• UDI-Public: 0506019107017
• Combination Product (y/n): N
• PMA/PMN Number: K192242
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1