MAUDE Adverse Event Report: C-RAD POSITIONING AB C4D SOFTWARE; SOFTWARE FOR RADIOTHERAPY POSITIONING SYSTEM

Model Number	CATALYST
Medical Device Problem Codes	Computer Software Problem (1112); Loss of Data (2903); Data Problem (3196)
Health Effect - Clinical Codes	Radiation Underdose (2166); No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Notification to customers: customers must make sure that an initiated save reference operation in c4d is fully completed before the linac treatment management system operator selects a new field.
Event or Problem Description
In presetup-settings state the user is able to crop the volume of interest for the cposition reference to desired size.The user needs to press save in order for the new cropped cposition reference to become active.If save is not pressed there will be no change to the cposition reference.When save is pressed a user dialogue is presented "the edited reference will become the active reference.Do you want to continue yes/no?" upon confirming with a yes, the reference is saved.If a new field is selected at the linac, c4d will automatically enter the presetup state and show the presetup screen.The potential issue is if a new field for the same patient is selected when the user was editing a reference and pressed save but did not acknowledge the confirmation dialogue.If the user then confirms the save reference operation after the new field was selected, c4d will assign the reference to the site which the new fields belongs to if the patient is the same.This is an issue if the new field belongs to another site than the first one.

• Brand Name: C4D SOFTWARE
• Common Device Name: SOFTWARE FOR RADIOTHERAPY POSITIONING SYSTEM
• Manufacturer (Section D): C-RAD POSITIONING AB; bredgrand 18; uppsala, uppsala 75320 ; SW 75320
• MDR Report Key: 9834353
• Report Number: 3006621300-2020-00001
• Device Sequence Number: 2421489
• Product Code: IYE
• UDI-Device Identifier: 07350005280024
• UDI-Public: 07350005280024
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K113276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: CATALYST
• Device Catalogue Number: SP-002
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1