inforMED
MalfunctionDPZ

OXIMAX N-595 PULSE OXIMETER

Received Jun 26, 2014 · Event occurred Jun 1, 2014

Report 2936999-2014-00562 · MDR key 3960782

Device

Generic name

Pulse Oximeter

Manufacturer

Covidien

Model number

N-595

Catalog number

N595

Product problems

  • Device Alarm System

Patient

Not reported

  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN BY THE BIOMEDICAL ENGINEER THAT THIS N-595 HAS NO AUDIO. THE FACILITY BIOMED ENGINEER ISOLATED THE ISSUE TO THE MAIN PCB BOARD. THERE WAS NO PT INVOLVEMENT REPORTED.