MAUDE Adverse Event Report: NATUS NEURO INCORPORATED SUBDURAL POST CRANIOTOMY ICP MONITORING KIT; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	1104G
Medical Device Problem Code	Inappropriate Waveform (2536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Customer confirms no patient injury, dhr review finds no anomalies.
Event or Problem Description
Waveform output not displayed while in use.

• Brand Name: SUBDURAL POST CRANIOTOMY ICP MONITORING KIT
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8533467
• Report Number: 3010611950-2019-00021
• Device Sequence Number: 2346591
• Product Code: GWM
• UDI-Device Identifier: 10381780025511
• UDI-Public: 10381780025511
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962928
• 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): 10/08/2018

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: 1104G
• Device Catalogue Number: 1104G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 04/19/2019
• 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