MAUDE Adverse Event Report: NUCLETRON B.V. FLEXITRON; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Flexitron hdr treatment software crashed on last 1.5 minutes left of treatment.Emergency backup activated and treatment continued but then went down, manual administration completed.Taken out of service and vendor and biomed notified.Manufacturer response for high dose rate brachytherapy afterloader, flexitron (per site reporter).Vendor will also place a ticket on their end.

• Brand Name: FLEXITRON
• Common Device Name: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON B.V.; 400 perimeter center terrace, suite 50; atlanta GA 30346
• MDR Report Key: 18310199
• Report Number: 18310199
• Device Sequence Number: 6628097
• Product Code: JAQ
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/12/2023
• Report Date (Section F): 10/12/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 10/12/2023