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

Model Number	CAM02
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Customer confirms device was in contact with patient however there was no injury or delays in surgery.Failure found when patient was about to be unplugged from the unit.Battery was found to be dead, swapped out with another monitor while defective unit was attempted to be charged, however no charge was able.Battery symbol continues to show with an "x" through it.Customer agreed to return product for additional evaluation.
Event or Problem Description
Monitor currently plugged in, however external battery indicator shows as not charging.
Additional Manufacturer Narrative
Reference sr (b)(4) for original complaint information.Product was returned on (b)(6) 2019 where depot repair confirmed the original reported serial number was incorrect.New sr was opened, sr (b)(4) to identify corrected serial number, sn: (b)(4).Depot repair confirmed unit was out of calibration.Per page 89 of cam02 ifu, unit requires annual maintenance to ensure proper function.

• 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: 9402902
• Report Number: 3010611950-2019-00073
• Device Sequence Number: 11506466
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 11/07/2019

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: 12/07/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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