inforMED
MalfunctionDPZ

OXIMAX N-560 PULSE OXIMETER

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

Report 2936999-2014-00670 · MDR key 4004725

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

Additional Manufacturer Narrative

COVIDIEN REF. NUMBER # (B)(4). NO PRODUCT WAS RETURNED TO COVIDIEN FOR INVESTIGATION. CUSTOMER WAS PROVIDED WITH THE PRODUCT PART NUMBER FOR THE FRONT PCB BOARD REPLACEMENT. SERIAL NUMBER PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MFR. .

Description of Event or Problem

COVIDIEN RECEIVED A REPORT THAT A UNIT HAD MISSING DISPLAY SEGMENTS. NO PT WAS INVOLVED IN THIS INCIDENT.