MalfunctionDPW

NEUROSENSOR COMBINED ICB/CBF PARACH PROBE

Received Sep 15, 2005

Report 2023988-2005-00042 · MDR key 664312

Device

Generic name

Neurosensor

Manufacturer

Integra Neurosciences

Model number

Catalog number

NS-P

Lot number

Product problems

Break
Disconnection

Patient

Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THREE INCIDENTS INVOLVING THREE SEPARATE PTS WERE REPORTED BY THIS USER FACILITY. USER FACILITY REPORTED THAT AFTER THE PROBE WAS INSERTED AND WHILE THE PT WAS IN TRANSIT FOR A CT SCAN, THE CATHETER CONNECTOR DISCONNECTED, FELL TO THE GROUND AND WAS STEPPED ON, RESULTING IN IT BREAKING. MONITORING WAS UNABLE TO BE CONTINUED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS MEDICAL DEVICE REPORT IS LINKED TO MEDICAL DEVICE REPORT #2023988-2005-00044 AND #2023988-2005-00045.