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

Lot Number	600001
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use (ifu) do not contain a warning that contraindicates imaging with unity in pregnancy.A possible scenario is that due to this warning not being present, the user is unaware of this contraindication and the user allows a pregnant patient to be imaged on the mr linac.The hazardous scenario is that the user incorrectly enters the patient as mr eligible when they are not (due to pregnancy).Note, in current mr radiology practice, users are able to make changes to the available sequences to limit the sar and rf exposure to the foetus.This is not possible on the unity system.The hazardous situation in this case is that the foetus is exposed to excessive rf energy whilst being imaged using the mr linac.The severity of the harm is considered serious.The severity has been assessed as serious and the probability of occurrence of harm is implausible.The risk level has been assessed to be low.
Event or Problem Description
No adverse event has occurred.Warnings regarding pregnancy and the mri imaging using the mr linac are not contained within the instructions for use.Under normal mr operating conditions (radiology use), pregnancy requires the mr user to make changes to available sequences in order to limit the specific absorption rate (sar) and radio frequency (rf) effects to the foetus.However, for unity access to and adjustment of these parameters is not available.Pregnant women are therefore contraindicated for imaging using the mr linac.The instructions for use do not contain a warning regarding contraindication for imaging in pregnancy.However, the system does have a rcm implemented in the form of a mr daily assessment checklist that contains a question on whether the patient is pregnant or not.If this answer to this question if "yes" - imaging would not start.

• Brand Name: UNITY
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• MDR Report Key: 8304539
• Report Number: 9617016-2019-00000
• Device Sequence Number: 1063931
• Product Code: IYE
• UDI-Device Identifier: 05060191071321
• UDI-Public: 05060191071321
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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
• Operator of Device: No Information
• Device Lot Number: 600001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1