inforMED
MalfunctionLIX

ONESTEP

Received Sep 5, 2025 · Event occurred Apr 15, 2025

Report 22976654 · MDR key 22976654

Device

Generic name

Aid, Cardiopulmonary Resuscitation

Model number

8900-000420-01

Lot number

4923L

Product problems

  • Device Alarm System
  • Expiration Date Error

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THREE EVENTS WITH ONESTEP CPR COMPLETE PADS WITH LOT#4923L FAILED A NIGHTLY SELF-TEST, NOTING EXPIRED PADS; HOWEVER, THE PRINTED EXPIRATION DATE ON PADS WAS WITHIN THE PRINTED DATE.