MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CAMINO ICP; COMPACT PORTABLE NEUROMONITOR (ICP & ICT)

Model Number	CAM02
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Device requested to be returned for additional evaluation sep.30th and oct.15th, 2019.Customer returned product on october 22, 2019.Depot repair confirmed product was out of calibration.
Event or Problem Description
Patient connected to catheter, then to monitor which did not show response.Monitor replaced with a backup unit which responded as expected.

• Brand Name: CAMINO ICP
• Common Device Name: COMPACT PORTABLE NEUROMONITOR (ICP & ICT)
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• MDR Report Key: 9252776
• Report Number: 3010611950-2019-00064
• Device Sequence Number: 2352254
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR