MAUDE Adverse Event Report: Natus Medical Incorporated NT821731C, EDS 3, GEN ll, NO CATHETER

Model Number	NT821731C
Medical Device Problem Codes	Break (1069); Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Nt821731c - natus evd stopcock cracked.Csf leaked through this crack, leading to inaccurate output and a break in the system.No patient injury.
Additional Manufacturer Narrative
Initial report ref to natus complaint#(b)(4).Per doc-035405 rev 15 risk analysis spreadsheet - eds 3 external drainage system hazard 4.40 - leakage of csf from the stopcock effect (harm): over drainage of csf and infection residual risk: medium stopcock leakage may result in unintended fluid loss and require device replacement.Implemented risk controls mitigate potential harm, and the clinical benefits of eds 3 in safe and accurate csf drainage continue to outweigh the residual risk.Related to capa005781.Further investigation to be carried out.

• Brand Name: NT821731C, EDS 3, GEN ll, NO CATHETER
• Common Device Name: NT821731C, EDS 3, GEN ll, NO CATHETER
• Manufacturer (Section D): Natus Medical Incorporated; 6225 nancy ridge dr; san diego, 92121 ; CA 92121
• Manufacturer Contact: 6225 nancy ridge dr; san diego, CA 92121
• MDR Report Key: 50426397
• Report Number: 2023988-2026-00073
• Device Sequence Number: 9095012
• Product Code: JXG
• UDI-Device Identifier: 00382830050555
• UDI-Public: 00382830050555
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2026

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: NT821731C
• Device Catalogue Number: NT821731C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/18/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 08/28/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown