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

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.

• 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 Key: 7662380
• MDR Text Key: 113552036
• Report Number: 9617016-2018-00002
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K012289
• Number of Events Reported: 1
• 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 Number: 1506573
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 07/04/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1