inforMED
MalfunctionOCH

MEDLINE

Received Jul 7, 2026 · Event occurred Jun 9, 2026

Report 1417592-2026-04616 · MDR key 25742487

Device

Generic name

Oximeter, Pulse, Fingertip, Led, W/ Case

Catalog number

HCSM70J

Lot number

(10)202403045

Product problems

  • Output Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE FINGER PULSE OXIMETER WAS NOT WORKING. DESPITE PUTTING IN THE BATTERIES TO TEST THE UNIT, IT DIDN'T TURN ON. 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 OXIMETER WAS NOT WORKING.