inforMED
MalfunctionDPZ

OXIMAX N-560 PULSE OXIMETER

Received Oct 16, 2012 · Event occurred Sep 28, 2012

Report 2936999-2012-00531 · MDR key 2797360

Device

Generic name

Pulse Oximeter

Model number

N-560

Catalog number

N560

Product problems

  • Device Operates Differently Than Expected

Patient

Not reported

  • No Patient Involvement

Narrative

Description of Event or Problem

COVIDIEN SERVICE CENTER RECEIVED A REPORT OF AN AUDIO FAILURE. NO REPORT OF PT INVOLVEMENT RECEIVED.

Additional Manufacturer Narrative

COVIDIEN EVAL FOUND LOW VOLUME OF AUDIO ALARMS. THE UNIT HAS BEEN RETURNED TO THE MFR FOR EVAL.