ONESTEP 8900-000219-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00847946023348), received between Mar 13, 2017 and Feb 11, 2025 — classified as 4 deaths, 24 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE FAILED THE SELF-TEST USING THESE ONESTEP PEDIATRIC PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357478 ↗
• MalfunctionSep 9, 2024Patient 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. 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 20171290 ↗
• MalfunctionAug 28, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 2-MONTH-OLD MALE PATIENT, THE ELECTRODE PADS WERE DAMAGED DURING THE REMOVAL OF PACKAGING. 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 20085821 ↗
• MalfunctionAug 6, 2024

  INFANT PATIENT CAME INTO THE EMERGENCY DEPARTMENT BEING GIVEN CPR BY EMS CREW. PATIENT MOVED TO RESUSCITATION ROOM. STAFF OPENED PACKAGE OF ONESTEP CPR ZOLL MONITOR PADS, AND WHEN POSTERIOR PAD WAS PULLED FROM SHEET, THE PAD SEPARATED. IT SEPARATED BETWEEN THE BOTTOM WHITE FOAM PAD AND THE BLUE FOAM LAYER. THEY COMPLETELY SEPARATED. STAFF PLACED THE LAYERS BACK TOGETHER AND PLACED ON PATIENT BUT COULD NOT GET READING/RHYTHM. THEY OPENED ANOTHER ONESTEP MONITOR PADS PACKAGE, AND THE SAME THING HAPPENED, AGAIN ONLY TO THE POSTERIOR PAD. BY THIS TIME, THEY HAD PUT OTHER MONITOR ELECTRODES ON PATIENT, AND COULD SEE THAT HE WAS NOT IN A SHOCKABLE RHYTHM. THE FAILURE OF THE ZOLL ONESTEP PADS COULD HAVE BEEN DETRIMENTAL TO THE PATIENT BECAUSE IF HE WAS IN A SHOCKABLE RHYTHM, THEY WOULD HAVE WANTED TO USE THAT MONITOR TO SHOCK HIM, WHICH THOSE PADS HAVE THE ABILITY TO DO WHEN WORKING CORRECTLY. IN THIS CASE THOUGH, HE WAS NOT IN A SHOCKABLE RHYTHM; SO THE FAILURE OF THE ZOLL MONITOR PADS DID NOT CAUSE ANY HARM/INJURY. STAFF HAD THE ACTUAL ZOLL MONITOR CHECKED THREE DIFFERENT TIMES THAT DAY, AND ALL THREE TECHS SAID THE MONITOR WAS WORKING CORRECTLY, SO OUR CONCLUSION IS THE PADS WERE WHAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917101 ↗
• MalfunctionOct 4, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 17868336 ↗
• MalfunctionJan 9, 2023Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA THESE ATTACHED 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 16125807 ↗
• DeathNov 18, 2022Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 4-MONTH-OLD MALE PATIENT, THE ASSOCIATED DEVICE WAS UNABLE TO OBTAIN AND ECG SIGNAL USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Necrosis

  MAUDE report 15828771 ↗
• MalfunctionSep 28, 2022Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 15496775 ↗
• MalfunctionJul 8, 2022Patient 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 TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBERS 1218058-2022-00065, 1218058-2022-00067, 1218058-2022-00059 FOR SIMILAR REPORTS FROM THE SAME CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959390 ↗
• MalfunctionJul 8, 2022Patient 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 TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBERS 1218058-2022-00066, 1218058-2022-00067, 1218058-2022-00059 FOR SIMILAR REPORTS FROM THE SAME CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957346 ↗
• MalfunctionJul 8, 2022Patient 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 TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBERS 1218058-2022-00066, 1218058-2022-00065, 1218058-2022-00059 FOR SIMILAR REPORTS FROM THE SAME CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957318 ↗
• MalfunctionMar 15, 2022Packaging Problem; Packaging Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PATIENT, THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING AND THEY WERE UNABLE TO ATTACH THEM TO THE PATIENT CAUSING A DELAY IN THERAPY. 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 13771893 ↗
• DeathJan 6, 2022Packaging Problem; Packaging Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) YEAR OLD PATIENT (GENDER UNKNOWN), THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING AND THEY WERE UNABLE TO ATTACH THEM TO THE PATIENT CAUSING A DELAY IN THERAPY. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Necrosis

  MAUDE report 13181579 ↗
• MalfunctionDec 2, 2021Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE ATTACHED DEFIBRILLATOR WAS UNABLE TO OBTAIN AN ECG SIGNAL USING THESE 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 12919201 ↗
• MalfunctionSep 7, 2021Mechanical Problem; Mechanical Problem

  COMPLAINANT INDICATED THAT WHILE ANTICIPATING THE TREATMENT OF AN ALREADY DECEASED (B)(6) OLD FEMALE PATIENT, THAT A WIRE HAD BECOME DISLODGED FROM THE ELECTRODE PAD. COMPLAINANT INDICATED THAT UPON ASSESSMENT OF THE PATIENT, MOTTLING AND RIGOR MORTIS WERE APPARENT PRIOR TO USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436237 ↗
• MalfunctionApr 16, 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 DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679554 ↗
• MalfunctionApr 14, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING 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 11664515 ↗
• MalfunctionJan 3, 2020Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE WAS UNABLE TO CAPTURE PACING USING THESE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9545803 ↗
• MalfunctionNov 12, 2019Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEFIBRILLATOR DISPLAYED A "POOR PAD CONTACT" MESSAGE USING THESE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9311497 ↗
• DeathSep 11, 2019Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (B)(6) YEAR OLD FEMALE PATIENT IN SEVERE BRADYCARDIA TRANSITIONED TO PEA, THE ASSOCIATED DEVICE DISPLAYED A ?CHECK PADS? MESSAGE USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN PERFORMED CPR TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death

  MAUDE report 8996541 ↗
• MalfunctionMay 29, 2019Unable to Obtain Readings; Unable to Obtain Readings

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

  Patient problems: No Patient Involvement

  MAUDE report 8651614 ↗
• MalfunctionApr 26, 2019Packaging Problem; Packaging Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN) THE ELECTRODES COULD NOT BE REMOVED FROM THE PACKAGING. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER ELECTRODE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8557822 ↗
• DeathApr 4, 2019Pacing Problem; Pacing Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) YEAR-OLD FEMALE PATIENT, THE ASSOCIATED DEFIBRILLATOR FAILED TO PACE THE PATIENT WITH THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death

  MAUDE report 8484261 ↗
• MalfunctionApr 17, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

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

  Patient problems: No Patient Involvement

  MAUDE report 7437481 ↗
• MalfunctionMar 29, 2018Device Packaging Compromised; Device Packaging Compromised

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PEDIATRIC PATIENT (GENDER UNKNOWN), THE ELECTRODE PADS WERE UNABLE TO BE REMOVED FROM THE PACKAGING. THE ELECTRODES SUBSEQUENTLY RIPPED CAUSING UNNECESSARY DELAY IN PATIENT CARE WHILE THE CLINICIAN APPLIED ECG LEADS TO CONTINUE CARDIAC MONITORING OF THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7382478 ↗