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

Device Problems Computer Software Problem (1112); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

As an immediate action the affected users are recommended to: avoid selecting fields while in the setup workflow step, all other workflow steps are ok.Verify the loaded site at the pre-setup workflow step.If not correct, reload the selected field in the linac.Verify the active position reference at the setup workflow step.If being the position reference of an incorrectly loaded site, enter pre-setup and reload the selected field in the linac.Verify the current loaded field at the setup workflow step.If the field information is missing, enter pre-setup and reload the selected field in the linac.

Event Description

If a field is selected at the linac, c4d will automatically load the corresponding field when configured for treatment field patient synchronization (e.G.Elekta icom or varian adi interfaces).When a field of a new site is selected, c4d will automatically enter the pre-setup workflow step.When at the setup workflow step and selecting a field of another site for the current patient, an issue has been identified where c4d enter pre-setup with the current site remaining incorrectly loaded, not changing to the site of the selected field.If the user then continues to setup, the patient can be positioned according to the position reference of the incorrectly loaded site, which may result in a patient misalignment relative to the current field loaded in the linac.

• Brand Name: C4D SOFTWARE
• Type of Device: SOFTWARE FOR RADIOTHERAPY POSITIONING SYSTEM
• Manufacturer (Section D): C-RAD POSITIONING AB; sjukhusvagen 12k; uppsala, uppsala 75309 ; SW 75309
• MDR Report Key: 10384419
• MDR Text Key: 227199902
• Report Number: 3006621300-2020-00002
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K113276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other