MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT

Model Number	1104HMT
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).07-nov-2024: natus received notice of display issue on cam02, sn: (b)(6).User could not continue with procedure due to pressure issues.Device needed to be changed, causing a delay in procedure.The catheter was replaced.This camino system cam02, sn: (b)(6).Used at the time is past due for the yearly calibration on (b)(6) 2022.Further review of complaint details to be carried out.
Event or Problem Description
Micro ventricular bolt icp / temp.Monitoring kit - user could not continue with procedure due to pressure issues.The patient was admitted to the neurosurgery ward of the hospital due to cerebral hernia.The patient was scheduled for surgery.Intraoperative intracranial pressure monitoring could not measure the pressure, the operation was delayed, and the reading returned to normal after replacing new devices.No injuries.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint # (b)(4).No associated capas.Complaint history review/trend analysis: (24 months review and percent of sales) 0 previously confirmed "integ-pressure" complaints within the past two years.(b)(4).1104hmt 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 05), identifies the hazard situation as "12.23 does not measure intracranial pressure accurately: non-robust module end electronics design or materials / for intended use" based on complaint of "pressure not reading." the risk level is considered low.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 any further information regarding the alleged complaint.Failure mode: no device returned - unable to determine.
Event or Problem Description
Micro ventricular bolt icp / temp.Monitoring kit - user could not continue with procedure due to pressure issues.The patient was admitted to the neurosurgery ward of the hospital due to cerebral hernia.The patient was scheduled for surgery.Intraoperative intracranial pressure monitoring could not measure the pressure, the operation was delayed, and the reading returned to normal after replacing new devices.No injuries.

• Brand Name: MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT
• Common Device Name: MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego; CA 92121
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 20722328
• Report Number: 2023988-2024-00080
• Device Sequence Number: 17082986
• Product Code: GWN
• UDI-Device Identifier: 00382830047531
• UDI-Public: 00382830047531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2024

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: 1104HMT
• Device Catalogue Number: 1104HMT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 11/28/2024
• 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 Age: 50 YR
• Patient Sex: Female