MalfunctionLIX
ONESTEP
Received Jul 15, 2025 · Event occurred Jun 17, 2025
Report 22507541 · MDR key 22507541
Device
Generic name
Aid, Cardiopulmonary Resuscitation
Manufacturer
Zoll Medical CorporationModel number
8900-0224-01Lot number
LOT 0424C
Product problems
- Defective Device
- Failure of Device to Self-Test
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING A TEST OF THE ONESTEP COMPLETE RESUSCITATION ELECTRODE PAD ON THE CPR [CARDIOPULMONARY RESUSCITATION] TRANSPORT CART, THIS PAD DID NOT PASS THE TEST - THE MONITOR ONLY SAID, 'CHECK PADS'. THE NURSE CHANGED THIS PAD TO A NEW PAD AND THE NEW ONE DID SUCCESSFULLY PASS THE TEST. ACTION TAKEN: DEFECTIVE PAD WAS SAVED IN THE QUALITY DEPARTMENT AND ZOLL CAN REQUEST SUBMITTER TO RETURN THE DEVICE FOR INSPECTION AND/OR FURTHER QUESTIONS.