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

Model Number 8B

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2021

Event Type  Injury  

Event Description

Clinic has been using raystation 8b with a couch model that they had not validated.The density defined in the couch model did not match that of the actual density of the couch, leading to inaccurate dose calculation.Severity and number of patients affected are not known.We have requested more information about dates, number of patients etc from the clinic.Incident(s) caused by use error.There was no malfunction in raystation.

• Brand Name: RAYSTATION
• Type of Device: RADIATION THERAPY TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): RAYSEARCH LABORATORIES AB (PUBL); sveavagen 44; stockholm, 11134 ; SW 11134
• Manufacturer (Section G): RAYSEARCH LABORATORIES AB (PUBL); sveavagen 44; stockholm, 11134 ; SW 11134
• Manufacturer Contact: david hedfors ; p.o. box 3297; stockholm, 10365 ; SW 10365
• MDR Report Key: 11951648
• MDR Text Key: 254809398
• Report Number: 3007774465-2021-00001
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• PMA/PMN Number: K200569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8B
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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