MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	110-4B
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Test Result (2695)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility, on 3 different occasions, on 3 different patients, the 110 4 b catheter was connected to monitor - was reading a normal icp (0 to 15 mmhg), then dropped to a negative number.One occurred out of box, the other occurred a day later.Date of incident: sometime during week of (b)(6), client unsure of exact dates.Device in contact with patient: 110 4 b, olm parenchymal catheter.Patient injury/ death alleged: none.Revision/medical intervention required: none.Patient prepped for surgery: not applicable.Patient information: do not have.Delay in surgery due to late receipt of product: not applicable.Delay in surgery due to product problem: not applicable.Additional information received via email on (b)(6) 2018: "we are happy to provide whatever additional info is needed.We recently had a very concerning issue in which we had a patient who had a camino placed and then replaced due to negative numbers during the day.It was negative again after shift change.The patient had to be rescanned to see if there were changes.His neuro exam was unchanged but had a very poor exam.A second camino was placed and the read was 54.- first reading negative 7.The patient was provided treatment for his icps including medication and a ventriculostomy placement.The number for the ventric matched the second camino initially.This patient had 2 more ct scans ( 3 within 12 hours) in order to help guide treatment as assess his brain.The second camino changed to negative within the next 12 hours.I attempted to save the camino, but somehow it was discarded.I can probable find out the lot number from our central supply.This was placed by experienced providers." additional information received via email (b)(6) 2018: "site is experiencing large swings in readings to the negative side after the catheter has been zero'd and placed.This is occurring possibly 24-48 hours into use." cross reference mdr# 2023988-2018-00046.

• Brand Name: (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center blvd.; san diego CA 92121
• MDR Report Key: 7785846
• Report Number: 2023988-2018-00045
• Device Sequence Number: 227904
• Product Code: GWM
• UDI-Device Identifier: 10381780023623
• UDI-Public: 10381780023623
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K102875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 110-4B
• Device Catalogue Number: 1104B
• Device Lot Number: 361366-H16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/15/2018
• 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: Required Intervention