ONESTEP 8900-0224-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 492 adverse event reports that list this exact device (DI 00847946016272), received between Aug 4, 2015 and Sep 30, 2026 — classified as 15 deaths, 36 injuries, 441 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (173 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 492 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 50947537 ↗
• MalfunctionSep 17, 2026Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED SELF TEST 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 50804517 ↗
• MalfunctionSep 4, 2026Gel Leak; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE AN 64-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN AND GEL MIGRATION.COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612976 ↗
• MalfunctionSep 4, 2026Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR FAILED SELF TEST.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612234 ↗
• InjuryAug 28, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING AN 85-YEAR-OLD FEMALE PATIENT, AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 50497987 ↗
• MalfunctionAug 24, 2026Packaging Problem

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODE PADS WOULD NOT DETACH FROM PLASTIC BACKING DURING OPENING/REMOVAL OF PACKAGING.COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 50406273 ↗
• MalfunctionAug 17, 2026Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED SELF TEST 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 50275253 ↗
• MalfunctionAug 14, 2026Sparking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253535 ↗
• MalfunctionAug 12, 2026Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222274 ↗
• MalfunctionAug 11, 2026Gel Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208860 ↗
• MalfunctionMay 15, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE RECOGNIZED THE ATTACHED ADULT ELECTRODES AS PEDIATRIC ELECTRODES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184524 ↗
• MalfunctionMay 1, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE DISPLAYED A "GENERAL ELECTRODE FAULT" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ONESTEP PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056056 ↗
• InjuryApr 8, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUFFERED BURNS. NO INFORMATION WAS AVAILABLE ON THE DEGREE OF BURNS.

  Patient problems: Burn(s)

  MAUDE report 24815567 ↗
• InjuryApr 7, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUFFERED BURNS. NO INFORMATION WAS AVAILABLE ON THE DEGREE OF BURNS.

  Patient problems: Burn(s)

  MAUDE report 24802291 ↗
• MalfunctionMar 30, 2026Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED SELF TEST 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 24728228 ↗
• MalfunctionMar 19, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODE PADS EXPERIENCED ADHESIVE PROBLEMS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 24643489 ↗
• MalfunctionMar 3, 2026Electrical Shorting

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498395 ↗
• MalfunctionMar 3, 2026Material Separation; Sparking

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 66-YEAR-OLD MALE PATIENT, AFTER MULTIPLE DISCHARGES THE PADS WERE REPLACED, THE PATIENT'S CHEST WAS WIPED, AND UPON SHOCK DELIVERY A SPARK WAS OBSERVED FROM THE DEFIBRILLATION PADS. IT WAS ALSO REPORTED THAT THE WIRE SEPARATED FROM THE ELECTRODE. NO BURNS WERE OBSERVED ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THE PATIENT SUBSEQUENTLY EXPIRED BUT WAS NOT A RESULT OF THE MALFUNTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496135 ↗
• MalfunctionMar 2, 2026Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 63-YEAR-OLD MALE PATIENT, THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE ONE-STEP PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483492 ↗
• MalfunctionFeb 27, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THE ATTACHED ELECTRODES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470239 ↗
• MalfunctionFeb 20, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT AN 81-YEAR-OLD PATIENT (GENDER UNKNOWN), A GROUND WIRE APPEARED TO REMAIN ATTACHED TO THE DEFIBRILLATION PADS WHILE ON THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. MEDWATCH NUMBER:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405418 ↗
• MalfunctionFeb 20, 2026Unable to Obtain Readings

  THE ASSOCIATED DEVICE FAILED THE SELF-TEST USING THESE ONESTEP PADS, THE DEVICE DISPLAYED A "PADDLE FAULT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402201 ↗
• MalfunctionFeb 16, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 72-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. THREE SETS OF ELECTRODES WERE USED DURING THE PATIENT EVENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 24344242 ↗
• MalfunctionFeb 13, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 72-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. THREE SETS OF ELECTRODES WERE USED DURING THE PATIENT EVENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 24338085 ↗
• MalfunctionFeb 13, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 72-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. THREE SETS OF ELECTRODES WERE USED DURING THE PATIENT EVENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 24338074 ↗