inforMED
MalfunctionNLF

NELLCOR PULSE OXIMETER PROBE

Received May 31, 2026 · Event occurred Apr 21, 2026

Report 3032391-2026-00023 · MDR key 25344030

Device

Generic name

Sensor, Lncs, Neonatal

Manufacturer

Medline Renewal

Catalog number

MAXNR

Lot number

202202

Product problems

  • Imprecise or Erratic Results

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT UNIT EXPERIENCED A REPROCESSED PULSE OXIMETER THAT MALFUNCTIONED, WHEN IT WAS PLACED THEY WERE UNABLE TO OBTAIN A CONSISTENT READING. 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 THAT, UNIT EXPERIENCED A REPROCESSED PULSE OXIMETER THAT MALFUNCTIONED, WHEN IT WAS PLACED THEY WERE UNABLE TO OBTAIN A CONSISTENT READING.