inforMED
MalfunctionDPZ

OXIMAX N-560 PULSE OXIMETER

Received Jun 25, 2014 · Event occurred May 1, 2014

Report 2936999-2014-00542 · MDR key 3958929

Device

Generic name

Pulse Oximeter

Manufacturer

Mediana

Model number

N-560

Catalog number

N560

Product problems

  • Component Missing

Patient

Not reported

  • No Patient Involvement

Narrative

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN THAT THE DISPLAY IS MISSING SEGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

COVIDIEN SERVICE CENTER REPLACED THE MAIN BOARD AND DISPLAY BOARD. (B)(4). THE SERIAL NUMBER OF THE DISPLAY PCB PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER.