MalfunctionLIX
ONESTEP
Received Sep 5, 2025 · Event occurred Apr 15, 2025
Report 22976654 · MDR key 22976654
Device
Generic name
Aid, Cardiopulmonary Resuscitation
Manufacturer
Zoll Medical CorporationModel number
8900-000420-01Lot 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.