inforMED
MalfunctionDPZ

OXIMAX N-560 PULSE OXIMETER

Received Apr 30, 2014 · Event occurred Apr 11, 2014

Report 2936999-2014-00391 · MDR key 3888553

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

RECEIVED A REPORT THAT THE N-560 IS MISSING SEGMENTS ON THE SATURATION PORTION OF THE DISPLAY. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PT.

Additional Manufacturer Narrative

(B)(4). THE CONDITION WAS VERIFIED BY COVIDIEN-(B)(6) SERVICE CENTER. THE FRONT PCB BOARD WAS REPLACED.