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

Lot Number	600011
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.As a result of this event, all sites have had a retrospective review of the stw offset values.12 machines had their value review, 9 of the machines are clinical and include 100% of the clinical systems.Only one axis at one site had an offset value >5mm (8.11mm), all other values were <3.5mm with the majority being <1mm.No machine had a mismatch between the stw and stored eq database offset values.Mr to mv alignment offset data may not be exported to equator database.The values are manually set to 0,0,0 by monaco/mosaiq installers to run necessary clinical workflow tests.This set is executed before or after setting to work phase where mr to mv alignment is run and results should be exported to equator.
Event or Problem Description
The customer reported that the mr to mv value cannot be checked.

• Brand Name: UNITY
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 8640069
• Report Number: 9617016-2019-00005
• Device Sequence Number: 14118974
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: Health Professional
• Device Lot Number: 600011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1