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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 Use of Device Problem (1670); Compatibility Problem (2960)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
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 that there appeared to be potential for couch moves to be applied multiple times.Based on the available information there has been no actual mistreatment.
 
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 activation 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 Key7913948
MDR Text Key122165349
Report Number9617016-2018-00008
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 Received09/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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