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

Model Number CAM02

Device Problem No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

Event Type  malfunction  

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 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
• Type of Device: COMPACT PORTABLE NEUROMONITOR (ICP & ICT)
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: janessa boone ; 3150 pleasant view road; middleton, WI 53562 ; 6088298603
• MDR Report Key: 9252776
• MDR Text Key: 172866193
• Report Number: 3010611950-2019-00064
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR