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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA LTD XVI; ACCELERATOR, LINEAR, MEDICAL
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ELEKTA LTD XVI; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problems Computer Operating System Problem (2898); Compatibility Problem (2960)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The incident results from failure of a windows message queue to advise successful completion of a couch move.This can result from issues with network traffic.
 
Event Description
The customer reported that after taking an image on xvi the shifts were correctly sent to mosaiq, then after achieving the correct couch positions and coming out of the mosaiq couch shift box an xvi pop up would give an option to re-send the couch shifts again.
 
Manufacturer Narrative
The risk assessment concluded as follows: severity: if unnoticed, a shift performed twice could put an organ-at-risk in the path of the mv beam, and potentially result in death or severe injury.(major).Likelihood: the initiating event is human error, the likelihood probable.The workflow is unusual, to result in harm, the user must: choose to resend the move when there is a visual indicator on the cma activiation that the results have been received by mosaiq and move the patient using the asu buttons even though this task will have been recently completed.
 
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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 Key8098831
MDR Text Key128564650
Report Number9617016-2018-00009
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
PMA/PMN Number
K131965
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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