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U.S. Department of Health and Human Services

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

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ELEKTA LTD ELEKTA INFINITY; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problem Noise, Audible (3273)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2020
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 the gantry noise caused by steel ball embed into the drum.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information and it was ascertained that elekta infinity was working as designed and intended.A steel ball found embedded in a gantry rim was removed before meaningful tests could be conducted on site.Subsequent iso-centre measurements showed that the machine was within specification and no significant damage had been done.The fault was introduced to a machine in a test shelter.There was a negligible effect (0.01cm) on iso-centre accuracy during an image acquisition using a pelvis phantom.A mechanical iso-centre test showed that there was a resulting change in source to surface distance of up to 2mm and it is calculated that this could result in clinically insignificant errors of 0.4% in the delivered dose and 0.2% in the field size.This would only happen at a specific gantry rotation angle of 110° and significant mistreatment to a patient is thought to be extremely unlikely.
 
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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 Key10249496
MDR Text Key198392359
Report Number9617016-2020-00005
Device Sequence Number1
Product Code IYE
UDI-Device Identifier00506019107017
UDI-Public0506019107017
Combination Product (y/n)N
PMA/PMN Number
K192242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/12/2020
Initial Date FDA Received07/09/2020
Supplement Dates Manufacturer Received06/12/2020
Supplement Dates FDA Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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