ONESTEP 8900-0222-01Recalls & reported problems

Zoll Medical Corporation · ELECTRODES, ONESTEP PACING, SINGLE, R SERIES · Class 3

All models of ONESTEP (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847946016258), received between Aug 13, 2018 and Jun 14, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Defibrillation/Stimulation Problem1
Failure to Deliver Shock/Stimulation1
Patient Device Interaction Problem1
Unable to Obtain Readings1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Burn(s)1
No Patient Involvement1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 14, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17126101 ↗
MalfunctionMar 19, 2022Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13828210 ↗
InjuryApr 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A (B)(6) FEMALE PATIENT, AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. PATIENT SUSTAINED BURNMARKS. THIS IS ALL THE INFORMATION AVAILABLE.
Patient problems: Burn(s)
MAUDE report 11614820 ↗
MalfunctionAug 13, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR DISPLAYED A "CHECK PADS" MESSAGE USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7776774 ↗

Device details

UDI-DI	`00847946016258`
Brand	ONESTEP
Model	8900-0222-01
Company	Zoll Medical Corporation
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Feb 3, 2026

Device type (GMDN): Multifunction cardiac treatment electrode

An electrical conductor designed to be applied to an adult and/or paediatric patient for automatic or manual defibrillation, external pacing, and cardioversion through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses (e.g., defibrillator); it commonly will also be used for electrocardiographic monitoring. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.

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All Automated external defibrillators (non-wearable) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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