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	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Nt821731c - stopcock at the transducer broke.No injuries.
Additional Manufacturer Narrative
Initial report ref to natus complaint# (b)(4) (b)(4) rev 13 risk analysis spreadsheet - eds 3 external drainage system hazard 4.9 - the stopcock at the bottom of the burette tube fails during the operation (unable to turn the stopcock valve and/or breakage of the valve) effect (harm): over drainage/under drainage of csf 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.Related to capa005781.Further investigation to be carried out.
Event or Problem Description
Nt821731c - the evd broke at the stopcock to transducer.No injuries.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint# (b)(4).Sterile date of the affected part: 16 sep 2025.Device history record review: unit has passed all the required tests.No manufacturing defects or non-conformances observed.Refelated to capa005781.Risk management review: a review of (b)(4) medical device hazard analysis (rev 14), identifies the hazard situation as "4.36 - stopcock valve unable to turn / rotate and/or handle breakage." the risk level is considered moderate.Based on complaint of "broken stopcock." this determination is based on the information received from the customer.Root cause/failure investigation: this case had a drainage system with a damaged system, patient-line, and drip chamber stopcock.The system stopcock was broken at the lever which is used to turn the stopcock into a closed or open position.The patient-line and drip chamber stopcock were broken at the hub.The system stopcock material exhibited significant deformation.The breakage of the system stopcock indicates that the user turned the stopcock with excessive torque possibly with a tool instead of by hand.Another possible indication could be that the client used aggressive cleaning agents that degrade the polycarbonate material.There was a buildup of dried blood/bodily fluids at the drip chamber stopcock.Assessment of whether bodily fluid exposure created an increased resistance during stopcock manipulation was inconclusive, as the device's rotational mechanisms were compromised due to structural breakage.Section "warnings" on page 3 of the eds 3 system ifu (sd208650001rev e) gives details on handling the eds 3 system such as finger tightening components and not using external tools.Failure mode: confirmed / stopcock breakage during use.

• 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: 24684715
• Report Number: 2023988-2026-00044
• Device Sequence Number: 15916316
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• 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: 33 YR
• Patient Sex: Female