MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821730C, EDS 3 GEN LL, WITH VENTRICULAR CATHETER

Model Number	NT821730C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint# (b)(4).No lot information provided by the customer.Capa005781 was opened to investigate the increase in complaint rates for the eds product line.Complaint history review/trend analysis: (24 months review and percent of sales) 1 previously confirmed "integ-broke in use" complaints within the past two years.(b)(4) nt821730c units sold within past two years.Failure rate = (b)(4).Risk management review: (identify hazard id) a review of (b)(4) medical device hazard analysis (rev 10), identifies the hazard situation as "4.40 leakage of csf from the stopcock." the risk level is considered moderate.Based on complaint of "stopcock leaking csf" this determination is based on the information received from the customer.Root cause/failure investigation: the customer did not return the device for evaluation or provide further information on the failure.Devices are fully tested prior to release of product.No further action is required; complaints will be tracked and trended for recurring issues.Failure mode: no device returned - unable to determine.
Event or Problem Description
Nt821730c - stopcock that is leaking csf.

• Brand Name: NT821730C, EDS 3 GEN LL, WITH VENTRICULAR CATHETER
• Common Device Name: NT821730C, EDS 3 GEN LL, WITH VENTRICULAR CATHETER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego 92121
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego 92121
• MDR Report Key: 22852086
• Report Number: 2023988-2025-00096
• Device Sequence Number: 11866996
• Product Code: JXG
• UDI-Device Identifier: 00382830050548
• UDI-Public: 00382830050548
• 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
• Report Date (Section B): 08/20/2025

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: NT821730C
• Device Catalogue Number: NT821730C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/20/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female