inforMED
MalfunctionDPW

NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL

Received Sep 15, 2005

Report 2023988-2005-00044 · MDR key 664302

Device

Generic name

Neurosensor

Model number

*

Catalog number

NS-P

Lot number

W050708

Product problems

  • False Reading From Device Non-Compliance

Patient

*

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

Narrative

Description of Event or Problem

THREE INCIDENTS WERE REPORTED BY THIS USER FACILITY. WHILE ZEROING THE ICP PORTION OF THE PROBE, A SIGNIFICANT DIFFERENCE BETWEEN THE PROBE READINGS IN THE VIAL AND THE PROBE READINGS OUTSIDE THE VIAL WERE OBSERVED. ALSO MENTIONED WERE BIG DIFFERENCES BETWEEN CBF MEASUREMENTS FROM THE GREY TO WHITE MATTER. THE PHYSICIAN EXPRESSED A GREATER CONCERN WITH THE DIFFERENCE IN THE ICP MEASUREMENTS THAN WITH THE CBF MEASUREMENTS. THIS MEDICAL REPORT IS LINKED TO MEDICAL DEVICE REPORT 2023988-2005-00042 AND #2023988-2005-00045.