MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

Model Number	1104G
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Part cam02p - customer's system shows an error message.The catheter did not work in the or, it was disconnected from the monitor and patient was taken to icu.Same catheter was connected to a different camino and customer was still unable to get a reading.There was no patient harm.
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).Acceptable risk associated with the complaint as per line 5.4, severity - 3 in (b)(4) camino icp monitor risk analysis.No death or serious injury, considered a customer inconvenience.Calibration due date (b)(6) 2023.Install date: (b)(6) 2019.Further investigation to be carried out.
Event or Problem Description
Part 1104g subdural post craniotomy icp monitoring kit - customer's system shows an error message.The catheter did not work in the or, it was disconnected from the monitor and patient was taken to icu.Same catheter was connected to a different camino and customer was still unable to get a reading.There was no patient harm.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Mar 20, 2023 - related report 0502800000-2023-8006 was received through fda's medsun program.Complaint form returned.Customer confirmed there was no delay or injury with the patient, no additional medical intervention was required.Customer stated after placing the device it would not zero appropriately.Customer rebooted the device which produced an appropriate reading.The unit was disconnected to preserver the sterile field, then failed once reconnected.Customer clarified information of cam02s used.Acceptable risk associated with the complaint as per hazard id 12.21, severity - 3, in doc-047178 camino 110-4 series catheter kits - risk analysis.Moderate risk.Further review of information to be carried out.
Additional Manufacturer Narrative
Follow up report 002 ref natus complaint# (b)(4).On 20 mar 2023: related report (b)(4).Was received through fda's medsun program.On 28-feb-2023: complaint form returned.Customer confirmed there was no delay or injury with the patient, no additional medical intervention was required.Customer stated after placing the device it would not zero appropriately.Customer rebooted the device which produced an appropriate reading.The unit was disconnected to preserver the sterile field, then failed once reconnected.Complaint history was reviewed for the previous two years and found 0 confirmed complaints, giving a failure rate of (b)(4).The device history record for the device was reviewed, the raw materials used in the manufacturing met specifications and there were no anomalies observed during the manufacturing, packaging or inspection of the device or accessories while in process.No associated capa's.The root cause of the complaint could not be determined as the returned catheter was tested meeting specifications.The customer stated, "after placing the device it would not zero appropriately", per the directions for use, the catheter must be zeroed prior to insertion.Based on the catheter meeting specification, it appears this is a user error.
Event or Problem Description
Part 1104g subdural post craniotomy icp monitoring kit: customer's system shows an error message.The catheter did not work in the or, it was disconnected from the monitor and patient was taken to icu.Same catheter was connected to a different camino and customer was still unable to get a reading.There was no patient harm.

• Brand Name: SUBDURAL POST CRANIOTOMY ICP MONITORING KIT
• Common Device Name: SUBDURAL POST CRANIOTOMY ICP MONITORING KIT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego, ca 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: 16442037
• Report Number: 2023988-2023-00003
• Device Sequence Number: 12116785
• Product Code: GWM
• UDI-Device Identifier: 00382830047517
• UDI-Public: 00382830047517
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102875
• 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,Followup
• Report Date (Section B): 04/11/2023

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 Expiration Date: 08/05/2024
• Device Model Number: 1104G
• Device Catalogue Number: 1104G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 02/10/2023; 02/10/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/21/2023; 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 74 KG