inforMED
MalfunctionDPZ

OXIMAX N-595 PULSE OXIMETER

Received Jan 2, 2013 · Event occurred Dec 1, 2012

Report 2936999-2012-00646 · MDR key 2903806

Device

Generic name

Pule Oximeter

Manufacturer

Covidien

Catalog number

N595

Product problems

  • Device Operates Differently Than Expected

Patient

Not reported

  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

THE ISSUE WAS ISOLATED TO THE MAIN BOARD. THE UNIT IS NOT LONGER MANUFACTURED AND THE MAIN BOARD IS NO LONGER AVAILABLE. THE CUSTOMER WAS ADVISED OF THE END-OF-LIFE STATUS.

Description of Event or Problem

COVIDIEN RECEIVED A REPORT THAT DURING SERVICING OF EQUIPMENT THAT WAS BEING STORED, THE BIOMED NOTICED THAT THERE WAS NO AUDIO ON THE PULSE OXIMETER. THERE WAS NO PT INVOLVEMENT.