ONESTEP 8900-000405-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847946021160), received between Dec 13, 2018 and Sep 22, 2026 — classified as 1 death, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 38-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 50853732 ↗
• MalfunctionSep 22, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 38-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 50853710 ↗
• MalfunctionSep 21, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 38-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. 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 50839557 ↗
• MalfunctionAug 20, 2026Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE 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 50347166 ↗
• MalfunctionAug 3, 2026Sparking; Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114542 ↗
• MalfunctionFeb 13, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9707258 ↗
• DeathDec 17, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODE PADS WOULD NOT ADHERE AND SLID UPWARD ON THE PATIENT'S CHEST. WHEN THE ELECTRODE PADS WERE REMOVED THE GEL STAYED ON THE PATIENT'S CHEST. COMPLAINANT INDICATED THAT THE CLINICIAN PERFORMED CPR ON TOP OF THE SENSOR OF THE ELECTRODE PADS WHICH CAUSED THEM TO SLIP UPWARDS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER THEY BELIEVE IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

  Patient problems: Death

  MAUDE report 8171428 ↗
• MalfunctionDec 17, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODES WERE SLIPPING WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8169272 ↗
• MalfunctionDec 17, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN WHILE THE CLINICIAN WAS PERFORMING CHEST COMPRESSIONS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8168967 ↗
• MalfunctionDec 13, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE ELECTRODE PADS SLIPPED WHILE ATTACHED TO THE PATIENT AND ONCE THE PATIENT'S GOWN WAS REMOVED THE CLINICIAN NOTICED THE ELECTRODE GEL REMAINED ADHERED TO THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8160333 ↗