Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA LTD ELEKTA UNITY; ACCELERATOR, LINEAR, MEDICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELEKTA LTD ELEKTA UNITY; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Patient Involvement (2645)
Event Date 04/03/2020
Event Type  malfunction  
Manufacturer Narrative
Elekta's investigation found that there is a potential risk where legionella bacteria may be present in the unity machine room, specifically the heat exchanger condensation collection tray.This risk is only significant to service users working directly on the condensation collection tray and immediate area.Clinical users and patients have no exposure to this potential hazard.Elekta has identified an area within the elekta unity system that has the potential environmental conditions for legionella bacteria to form.The area with this potential is the condensation collection system for the heat exchanger located within the unity machine room.The unity machine room has restricted access and shall only be accessed by trained personnel.In normal operation there is no risk of any users or patients being exposed to legionella bacteria should it be present.There has been no reported presence of legionella bacteria in elekta unity systems, this has been identified as a potential hazard only.The presence of legionella bacteria in the unity machine room does not impact the safe operation of the system nor does it pose any change to delivery of a treatment.There is no change in risk to the patient or clinical user.Only service users working directly on the area of potential legionella bacterial growth are at risk.
 
Event Description
A potential risk to the service user of inhaling water contaminated with legionella bacterium was internally reviewed by elekta.
 
Manufacturer Narrative
The corrective actions taken as a result of this investigation was that service engineers have been informed not to perform any work on this region of the system without further advice.An important field safety notice 200-01-801-009 was sent to all affected customers from 12th may 2020.Formal advice is to follow and an important field safety modification (ifsm) is estimated to be released by august 2020.The ifsm is to replace the condensate sump to allow for simple and regular treatment of any potential stagnate water.This treatment will become part of the 3 monthly scheduled maintenance.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ELEKTA UNITY
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
ELEKTA LTD
linac house
fleming way
crawley, RH10 9RR
UK  RH10 9RR
MDR Report Key10013205
MDR Text Key200813492
Report Number9617016-2020-00003
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
PMA/PMN Number
K192482
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-