MAUDE Adverse Event Report: RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION; RADIATION THERAPY TREATMENT PLANNING SYSTEM

Model Number	RAYSTATION 9A, 9B, 10A, 10B INCLUDING SOME SERVICE PACKS
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
No event occurred.No patients were affected.There is only a potential health hazard discovered by the manufacturer.This issue concerns the display of flags in raytreat.Flags edited in raycare after a patient has been checked in may not always be updated in raytreat.
Additional Manufacturer Narrative
A design error has been identified.Raystation is closely integrated with raycare, which is a stand-alone software oncology information system (ois).Flags are entered in raycare to highlight risks, allergies, implantable devices, or other important information concerning the selected patient.Active flags are shown in the patient panel in raycare and are also propagated to raytreat and displayed there during the treatment delivery session.When a patient is checked in for treatment in raycare, it is verified that the flag status in raytreat is in sync with raycare.However, if flags are edited in raycare after patient checkin, the status may not be updated in raytreat.The behavior to rely only on flags status at checkin is as designed, but current analysis shows that this may introduce a risk of important information being overlooked at treatment delivery.In the event that critical information pertaining to a treatment session is missed, this could lead to unintended or inappropriate treatment.Worst case, a daily treatment could be performed although patient's health status is such that treatment should normally be delayed, potentially leading to more severe side effects than normally accepted.
Event or Problem Description
Follow-up of report rsa: mdr 3010034862-2023-00011 76812 rs rt flags not updated.No event occurred.No patients were affected.There is only a potential health hazard discovered by the manufacturer.This issue concerns the display of flags in raytreat.Flags edited in raycare after a patient has been checked in may not always be updated in raytreat.

• Brand Name: RAYSTATION
• Common Device Name: RADIATION THERAPY TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): RAYSEARCH LABORATORIES AB (PUBL); eugeniavaegen 18c; stockholm, se, 11368 ; SW 11368
• Manufacturer (Section G): RAYSEARCH LABORATORIES AB (PUBL)EUGENIAVAEGEN 18C,; eugeniavagen 18c; stockholm, 11368 ; SW 11368
• Manufacturer Contact: david hedfors ; eugeniavagen 18c; stockholm, 11368 ; SW 11368
• MDR Report Key: 16491734
• Report Number: 3010034862-2023-00011
• Device Sequence Number: 13917039
• Product Code: MUJ
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K210645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025
• Report Date (Section F): 03/06/2023

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: Other
• Device Expiration Date: 12/23/2025
• Device Model Number: RAYSTATION 9A, 9B, 10A, 10B INCLUDING SOME SERVICE PACKS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/03/2021
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 87666
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/06/2023