MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED FIXED PRESSURE SHUNTS

Model Number	NT8501210
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint # (b)(4).On 24 feb 2022 - the customer notified natus of a drainage issue that occurred in (b)(6) 2021.The unit is still available for evaluation, but the customer is unsure of the lot number.The customer was late to notify natus due to covid.The customer is requesting a replacement.Technical support confirmed that the complaint questionnaire was sent to the customer as well as information on how to return the product to cg labs for decontamination prior to product being returned to natus.Further investigation on the part will then be carried out.Acceptable risk as per (b)(4), hazard id no.12.8, severity - 11, moderate risk.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.Service repair investigations will be conducted during the repair process and trend data will be reviewed (b)(4).
Event or Problem Description
Part nt8501210 standard natus csf reservoir, 1.5cm dome, burr-hole - was not draining correctly.No injuries reported.
Event or Problem Description
Part nt8501210 standard natus csf reservoir, 1.5cm dome, burr-hole - was not draining correctly.No injuries reported.
Additional Manufacturer Narrative
Follow up report 001ref natus complaint # (b)(4).Technical support confirmed that the complaint questionnaire was sent to the customer as well as information on how to return the product to cg labs for decontamination prior to product being returned to natus.Four attempts were made to confirm if the product will be returned.Product was not returned, therefore unable to confirm the failure.There are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.Complaint history was reviewed for the past two years and found 0 previously confirmed complaints, giving a failure rate of (b)(4).Per qms-004442 complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified.Faillure confirmed: no investigation result code : san diego|eds products|no return of device for evaluation closure rationale: complaint could not be verified, materials not returned for analysis.Based on evaluation of this complaint there is no safety risk of harm, individual complaint related to issue stated.Complaint will be included in trending data for further review and investigation if needed.

• Brand Name: FIXED PRESSURE SHUNTS
• Common Device Name: FIXED PRESSURE SHUNTS
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego, 92121 CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego 92121, CA
• MDR Report Key: 13652623
• Report Number: 2023988-2022-00003
• Device Sequence Number: 12333356
• Product Code: JXG
• UDI-Device Identifier: 00382830057042
• UDI-Public: 00382830057042
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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): 05/19/2022

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: NT8501210
• Device Catalogue Number: NT8501210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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