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	04/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Nt821731c - the evd broke at the stopcock to the transducer during icp checks.No injuries.
Additional Manufacturer Narrative
Initial report ref to natus complaint# (b)(4).(b)(4) rev 14 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.Stopcock stem handle breakage may affect operation and require device replacement.Existing risk controls minimize likelihood, and the clinical benefits of eds 3, including safe and accurate csf drainage and prevention of complications, continue to outweigh the 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; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego 92121
• Manufacturer Contact: 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 24908844
• Report Number: 2023988-2026-00053
• Device Sequence Number: 21288949
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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: 118001162669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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 Age: 46 YR
• Patient Sex: Female