inforMED
MalfunctionDPZ

OXIMAX N-560 PULSE OXIMETER

Received Mar 21, 2014 · Event occurred Feb 21, 2014

Report 2936999-2014-00252 · MDR key 3807196

Device

Generic name

Pulse Oximeter

Manufacturer

Mediana

Model number

N-560

Catalog number

N560

Product problems

  • No Display/Image

Patient

Not reported

  • No Patient Involvement

Narrative

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN THAT THE PULSE AND SPO2 WERE NOT PROPERLY DISPLAYED. THE SEGMENTS WERE NOT LIT. THE FRONT BOARD WAS REPLACED AND THE UNIT IS WORKING WELL. THERE WAS NO PATIENT INVOLVED.

Additional Manufacturer Narrative

(B)(4).