MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821731C, EDS 3, GEN LL, NO CATHETER

Model Number	NT821731C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).(b)(4) rev 13 risk analysis spreadsheet - eds 3 external drainage system hazard 4.36 - stopcock valve unable to turn / rotate and/or handle breakage effect (harm): delay in patient treatment, over / under drainage of csf and infection residual risk: medium the hazards identified have been reduced as far as possible, and the benefit of use of the entire product outweighs the risks identified.Reference to capa005781.Further investigation to be carried out.
Event or Problem Description
Nt821731c - the stopcock broke off the ventricular drain.No harm to patient.
Event or Problem Description
Nt821731c - the stopcock broke off the ventricular drain.No harm to patient.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint# (b)(4).This is a duplicate report to 2023988-2026-00016.Ref to natus complaint # (b)(4).Further updates and investigation details will be documented under report# 2023988-2026-00016.

• 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; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 24545021
• Report Number: 2023988-2026-00037
• Device Sequence Number: 5662053
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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
• Device Lot Number: 118001162650
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown