inforMED
MalfunctionOCH

MEDLINE

Received Jul 12, 2026 · Event occurred Jun 15, 2026

Report 1417592-2026-05161 · MDR key 25791640

Device

Generic name

Oximeter, Pulse, Fingertip, Led, W/ Case

Catalog number

HCSM70J

Lot number

202603014

Product problems

  • Overheating of Device

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE REPORT STATES, "CUSTOMER USED HIS BLUECROSS POINT TO PURCHASE THE OXIMETER. THE CUSTOMER CALLED AS HE PUT THE BATTERY THAT CAME WITH THE PRODUCT IN AND HIT WORKED FOR 10 MINUTES, AND THEN GOT EXTREMELY HOT. HE TOOK THE BATTERY OUT AND REPLACED IT WITH A LITHIUM BATTERY AND THE ITEM STOPPED WORKING. CUSTOMER IS LOOKING FOR A REPLACEMENT AS HE USES THIS PRODUCT SOMETIMES ONCE A DAY AND THEN MOVED TO TWICE A WEEK, MANDATORY. DUE DILIGENCE HAS BEEN COMPLETED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. 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 MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

THE REPORT STATES, "CUSTOMER USED HIS BLUECROSS POINT TO PURCHASE THE OXIMETER. THE CUSTOMER CALLED AS HE PUT THE BATTERY THAT CAME WITH THE PRODUCT IN AND HIT WORKED FOR 10 MINUTES, AND THEN GOT EXTREMELY HOT. HE TOOK THE BATTERY OUT AND REPLACED IT WITH A LITHIUM BATTERY AND THE ITEM STOPPED WORKING. CUSTOMER IS LOOKING FOR A REPLACEMENT AS HE USES THIS PRODUCT SOMETIMES ONCE A DAY AND THEN MOVED TO TWICE A WEEK, MANDATORY."