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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CAMINO ICP; INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT
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NATUS NEURO INCORPORATED CAMINO ICP; INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT Back to Search Results
Model Number 1104BT
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/21/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Customer asked to provide follow up information regarding incident and return of device on august 12th, 19th and 27th, 2019.Product was returned to lab for decontamination, once complete will be sent to natus for additional evaluation.
 
Event or Problem Description
Catheter gave high readings compared to evd.
 
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Brand Name
CAMINO ICP
Common Device Name
INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT
Manufacturer (Section D)
NATUS NEURO INCORPORATED
5955 pacific center boulevard
san diego CA 92121
MDR Report Key8962508
Report Number3010611950-2019-00052
Device Sequence Number2562444
Product Code GWM
UDI-Device Identifier10381780023630
UDI-Public10381780023630
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K962928
Number of Events Summarized1
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) 08/21/2019
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 Number1104BT
Device Catalogue Number1104BT
Device Lot Number348141-A16
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/21/2019
Initial Report FDA Received Date09/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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