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

Model Number	CAM02
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).Customer documented inconsistent icp measurements involving the cam02 and 1104bt catheter (temperature measured ok).Customer states the first catheter indicated intracranial hypertension, however the neurosurgeon did not agree.Catheter was removed after three days, second catheter began to show a high value and then went flat.The cam02 then stopped sensing both the "pic and temperature".After catheter was removed, the monitor displayed error message indicating "sensor board failure".Customer provided additional background information confirming the following: both catheters were zeroed prior to insertion.Camcabl was not replaced during patient monitoring.Customer has another cam02 monitor to use.Calibration was due (b)(6) of 2020, however customer states the unit was just installed in (b)(6) 2020 and has only been used for 6 months.It is yet to determine if the catheters had any problem or if it was the monitor failure that caused all the trouble with this monitoring case, even though the error appeared at the end after removing the patient monitoring.A separate report has been opened to investigate the catheter involved part 1104bt ref 2023988-2021-00013.Affected product has been requested to be returned for evaluation.
Event or Problem Description
Customer documented inconsistent icp measurements involving the cam02.No patient injury.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Request for product return was made on may 25th, june 11th, june 21st and july 26th, 2021.Product was not returned therefore unable to perform functional testing.Review of product evaluation form shows dhr was reviewed and found no manufacturing defects or associated capas.Complaint history was reviewed for the previous two years and found 32 confirmed complaints, giving an incident rate of (b)(4).Review of medical device hazard analysis shows incident to identify as an acceptable risk.Depot repair could not confirm the failure as product was not returned.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.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.Acceptable risk associated with the complaint as per line 12.1 (b)(4) camino icp monitor risk analysis.Acceptable risk associated with the complaint as per line 12.2 (b)(4) camino icp monitor risk analysis.Dhr was reviewed and unit passed all required tests.No manufacturing defects or non-conformance was observed.Service repair investigations will be conducted during the repair process and trend data will be reviewed per qms-004442.A separate report was opened to investigate the catheter involved part 1104bt ref (b)(4).Closure rationale: complaint could not be verified, materials not returned for analysis.
Event or Problem Description
Customer documented inconsistent icp measurements involving the cam02.No patient injury.

• 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, ca 92121 CA
• MDR Report Key: 12018138
• Report Number: 2023988-2021-00012
• Device Sequence Number: 4777155
• Product Code: GWM
• UDI-Device Identifier: 00382830049023
• UDI-Public: 00382830049023
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1