inforMED
MalfunctionDPW

NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X

Received Jul 8, 2005

Report 2023988-2005-00026 · MDR key 737483

Device

Generic name

Neurorsensor

Model number

*

Catalog number

NS-P

Lot number

W050708

Product problems

  • High Readings

Patient

*

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

Narrative

Description of Event or Problem

WHILE IN USE, THE NEUROSENSOR PROBE HAD A SUDDEN RISE IN VALUES (CBF AND ICP). WHEN THE CBF NORMALIZED, THE ICP READ ZERO AND REMAINED AT ZERO FOR THE REMAINDER OF SURGERY. THERE WAS NO PT INJURY INVOLVED.

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.