ONESTEP 8900-0221-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00847946016241), received between Jun 8, 2017 and Apr 30, 2026 — classified as 1 death, 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT (AGE UNKNOWN), THE STAFF STATED THE POSTERIOR PAD HAD NO GEL ON IT. THE GEL WAS STUCK TO THE PACKAGING. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF 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 25047505 ↗
• MalfunctionJul 29, 2025Unable to Obtain Readings; Unable to Obtain Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647447 ↗
• MalfunctionMay 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODE PADS WERE UNABLE TO ATTACH 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 19375488 ↗
• MalfunctionMar 10, 2023Delayed Charge Time; Delayed Charge Time

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A MALE PATIENT (AGE UNKNOWN), AN ARC WAS HEARD FROM THE ELECTRODE PADS. 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 16526250 ↗
• MalfunctionDec 7, 2022Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THE ATTACHED ELECTRODE 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 15932676 ↗
• InjuryNov 22, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT (AGE UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY SUSTAINED A BURN. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON THE DEGREE OF THE BURN.

  Patient problems: Burn(s)

  MAUDE report 12857433 ↗
• MalfunctionAug 2, 2021Mechanical Problem; Arcing of Electrodes; Mechanical Problem; Arcing of Electrodes

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), AN ARC WAS SEEN COMING FROM THE ELECTRODE PADS AND A WIRE HAD BECOME EXPOSED FROM THE ELECTRODE PAD. 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 12261485 ↗
• MalfunctionJul 27, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL 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 12234935 ↗
• MalfunctionJul 9, 2021Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THE 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 12143486 ↗
• InjuryMay 14, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY SUSTAINED A BURN. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON THE DEGREE OF THE BURN. PLEASE REFERENCE MEDWATCH REPORT 1218058-2021-00072 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

  Patient problems: Burn(s)

  MAUDE report 11826710 ↗
• InjuryMay 13, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY SUSTAINED A BURN. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON THE DEGREE OF THE BURN. PLEASE REFERENCE MEDWATCH REPORT 1218058-2021-00071 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

  Patient problems: Burn(s)

  MAUDE report 11821515 ↗
• DeathNov 17, 2020Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT IS UNKNOWN IF THIS WAS A RESULT OF THE REPORTED MALFUNCTION.

  Patient problems: Death

  MAUDE report 10854215 ↗
• MalfunctionJan 29, 2020Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR DISPLAYED A "CHECK PADS" MESSAGE WITH THESE ELECTRODE PADS ATTACHED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9644518 ↗
• MalfunctionDec 29, 2017Failure To Adhere Or Bond; Gel Leak; Material Integrity Problem

  DEFIBRILLATOR PADS WERE NOT ADHERING TO SKIN. WE REMOVED THE SET OF PADS AND DISCOVERED GEL HAD MIGRATED AND CONGEALED IN CLUMP TO CENTER OF PAD AND SILVER PACKING WAS EXPOSED TO PATIENT'S BARE SKIN. THIS HAD HAPPENED ON BOTH DEFIBRILLATOR PADS ON SAME SET. PADS HAD BEEN PLACED ON THE PATIENT PRIOR TO PATIENT GOING TO OR AND THE SET OF DEFIBRILLATOR PADS WERE ON THE PATIENT FOR LESS THAN 24 HRS. WE SAW THIS SAME DEFIBRILLATOR PAD GEL CLUMP INTO ONE SPOT ON ANOTHER SET OF DEFIBRILLATOR PADS USED FOR ANOTHER PATIENT. TWO OCCURRENCES TWO DIFFERENT DEFIBRILLATOR PADS USED ON TWO DIFFERENT PATIENTS WITHIN 48 HOURS. STAFF DID NOT KEEP PACKAGING SO DO NOT KNOW LOT NUMBER OR EXPIRATION DATES. MANUFACTURER RESPONSE FOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE), ONESTEP (PER SITE REPORTER): UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153933 ↗
• MalfunctionDec 26, 2017Disconnection; Disconnection

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), THE CLINICIAN OBSERVED THAT A WIRE HAD BECOME DISLODGED FROM THE ELECTRODE PAD. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7146099 ↗
• MalfunctionJun 8, 2017Detachment Of Device Component; Detachment Of Device Component

  COMPLAINANT ALLEGED THAT WHILE TREATING A PATIENT (AGE & GENDER UNKNOWN) DURING TRANSPORT, A WIRE HAD BECOME DISLODGED FROM THE ELECTRODE PAD. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6622180 ↗