inforMED
MalfunctionNLF

NELLCOR PULSE OXIMETER PROBE

Received Jun 19, 2026 · Event occurred May 13, 2026

Report 3032391-2026-00037 · MDR key 25568360

Device

Generic name

Sensor, Lncs, Neonatal

Manufacturer

Medline Renewal

Catalog number

MAXNR

Lot number

202181

Product problems

  • Mechanical Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE O2 SENSORS ARE NOT AS STICKY AS THE ORIGINAL ONES ARE. WE ARE HAVING TO USE AT LEAST 2 SENSORS ON EACH PATIENT BECAUSE THEY ARE NOT STICKY. THEY HAVE TRIED WRAPPING WITH COBAN BUT EVENTUALLY THAT DOESN'T HELP AND SINCE IT STOPS STICKING IT DOESN'T HAVE AN ACCURATE READ AND THEY HAVE TO USE ANOTHER ONE. 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, THE O2 SENSORS ARE NOT AS STICKY AS THE ORIGINAL ONES ARE. WE ARE HAVING TO USE AT LEAST 2 SENSORS ON EACH PATIENT BECAUSE THEY ARE NOT STICKY. THEY HAVE TRIED WRAPPING WITH COBAN BUT EVENTUALLY THAT DOESN'T HELP AND SINCE IT STOPS STICKING IT DOESN'T HAVE AN ACCURATE READ AND THEY HAVE TO USE ANOTHER ONE,