MAUDE Adverse Event Report: XSTRAHL LTD RADIANT AURA; X-RAY RADIATION THERAPY SYSTEM

Model Number	RADIANT AURA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On the (b)(6) 2024, the arm joint became loose and this caused the arm to drop.The radiation therapist put her shoulder in the path of the arm to stop it from drooping further.No patient injury.Product problem: service visit to the user site found the following: measured existing upper arm joint torque with shims installed (19.2nm) as well as lower joint (18.6nm).Tightened joint screw to appropriate 20nm setting.During the testing at the user site, it was discovered that the arm joint brake would engage intermittently (approx 7 of 10 times).Tested the base unit pcb and discovered flickering of leds when failure would occur as if card was being shorted out.Also noticed the base hub rotary brakes were not operable at all (would not disengage).During fault finding procedure the base hub brake resistance reading was below tolerance at approx 15.7 ohms.Checked applicable brake cabling for discrepancies (damaged or cross wiring) and found none.

• Brand Name: RADIANT AURA
• Common Device Name: X-RAY RADIATION THERAPY SYSTEM
• Manufacturer (Section D): XSTRAHL LTD; unit 2; maybrook road; walsall, west midlands WS87D G; UK WS87DG
• Manufacturer (Section G): XSTRAHL LTD; unit 2; maybrook road; walsall, west midlands WS87D G; UK WS87DG
• Manufacturer Contact: sajid rafiq ; unit 2; maybrook road; walsall, west midlands WS87D-G ; UK WS87DG
• MDR Report Key: 19348479
• Report Number: 3004561814-2024-00002
• Device Sequence Number: 20653178
• Product Code: JAD
• UDI-Device Identifier: 05060494200084
• UDI-Public: 5060494200084
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K230611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: RADIANT AURA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown