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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA LTD IVIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID); ACCELERATOR, LINEAR, MEDICAL

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ELEKTA LTD IVIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID); ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Model Number 1506573
Device Problems Computer Software Problem (1112); Image Orientation Incorrect (1305)
Patient Problems No Known Impact Or Consequence To Patient (2692); 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 has reported that the iview port film has opened the plan shape but with an offset away from the intended area.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.If the planned shape does move during the double exposure workflow, it will be immediately detectable by the user which occured with this case.The radiographers noticed the error, cancelled the treatment session and did not treat the patient.The clinicians should be able to detect the misalignment of the open shape film and the closed shape in the double exposure image, even if the misalignment is minimal.The double exposure image should be rejected and a new set of images must be taken to complete the port film workflow.The customer site also rejected the misaligned image and had taken a new set of portal images and misalignment did not occur on any successive double exposure portal image.This issue is not a safety issue and can be concluded as no risk, detectable prior to use.
 
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Brand Name
IVIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
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 Key7662380
MDR Text Key113552036
Report Number9617016-2018-00002
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
PMA/PMN Number
K012289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 12/19/2018
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? No
Device Operator Health Professional
Device Model Number1506573
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/05/2018
Initial Date FDA Received07/04/2018
Supplement Dates Manufacturer Received06/05/2018
Supplement Dates FDA Received12/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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