inforMED
MalfunctionNLF

NELLCOR PULSE OXIMETER PROBE

Received Jun 22, 2026 · Event occurred May 26, 2026

Report 3032391-2026-00042 · MDR key 25585990

Device

Generic name

Sensor, Lncs, Neonatal

Manufacturer

Medline Renewal

Catalog number

MAXNR

Product problems

  • Imprecision

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED "SAT MONITOR DOES NOT STICK TO FINGER, WAVEFORMS POOR QUALITY RESULTING IN INACCURATE SATURATION READINGS." THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

Description of Event or Problem

IT WAS REPORTED "SAT MONITOR DOES NOT STICK TO FINGER, WAVEFORMS POOR QUALITY RESULTING IN INACCURATE SATURATION READINGS."