MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED COMPACT PORTABLE NEUROMONITOR (ICP AND ICT)

Model Number	CAM02
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Part cam02 - system error detecting a sensor board failure.Details from the customer as below: *-june 15, sensor placement is carried out, equipment working in perfect condition, proper functioning is confirmed with the doctor.*-patient hospitalized in icu, with pic intervals 15 to 20 mm hg.*-5 days the equipment working normally.* -6 days in the morning, the screen showed a system error detecting a failure in the sensor card.*- from then on, no more icp intervals were shown, unit was swapped out with another to continue patient monitoring.No medical intervention required.
Additional Manufacturer Narrative
Initial report (ref natus complaint no.Sr#(b)(4).Pictures of the product were provided by the customer and they also confirmed that the affected product will not be returned.Review of this serial number in the system shows this unit has never been calibrated by natus, confirmed by technical service.Per cam02 user manual, monitor requires annual maintenance to ensure proper function.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.Acceptable risk as per hazard id 12.1 in doc-033950 camino icp monitor risk analysis.Risk is considered to be moderate.Install date: (b)(6) 2016 further investigation to be carried out.
Additional Manufacturer Narrative
Follow up report 001 (ref natus complaint no.(b)(4).Complaint history was reviewed for the previous two years and found 41 confirmed complaints, giving a failure rate of 10.20%.Device history record was reviewed and no related faults/issue found.Failure 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.Complaint will be included in trending data for further review.
Event or Problem Description
Part cam02 - system error detecting a sensor board failure.Details from the customer as below: *-june 15, sensor placement is carried out, equipment working in perfect condition, proper functioning is confirmed with the doctor.*-patient hospitalized in icu, with pic intervals 15 to 20 mm hg.*-5 days the equipment working normally.* -6 days in the morning, the screen showed a system error detecting a failure in the sensor card.*- from then on, no more icp intervals were shown, unit was swapped out with another to continue patient monitoring.No medical intervention required.

• Brand Name: COMPACT PORTABLE NEUROMONITOR (ICP AND ICT)
• Common Device Name: COMPACT PORTABLE NEUROMONITOR (ICP AND ICT)
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego, 92121 CA
• Manufacturer (Section G): NATUS MANUFACURING LIMITED; ida business park; gort; galway, h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego 92121
• MDR Report Key: 17306796
• Report Number: 2023988-2023-00019
• Device Sequence Number: 12578038
• Product Code: GWM
• UDI-Device Identifier: 00382830049023
• UDI-Public: 00382830049023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121573
• 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): 08/21/2023

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 Model Number: CAM02
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Sex: Male