CPR STAT-PADZ 8900-0402Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00847946016319), received between Mar 16, 2017 and Jul 21, 2026 — classified as 6 deaths, 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• DeathJul 21, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 3-YEAR-OLD PATIENT (GENDER UNKNOWN) POST DROWNING, THE ELECTRODE PADS WOULD NOT ADHERE TO THE PATIENT'S SKIN. A 2ND SET OF ELECTRODE PADS WERE USED WITH THE SAME RESULTS. THE LOT NUMBERS OF THE PADS ARE LOT: 4525 AND LOT: 1825B. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. PLEASE REFERENCE MEDWATCH 1218058-2026-00101 FOR PADS LOT: 1825B.

  Patient problems: Insufficient Information

  MAUDE report 25894487 ↗
• MalfunctionJul 17, 2026Packaging Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN). THE ELECTRODE PADS (LOT NUMBER UNKNOWN) BECAME DAMAGED/RIPPED WHILE PEELING OFF THE REMOVEABLE CLEAR BACKING. 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 25856371 ↗
• MalfunctionJul 17, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25856351 ↗
• MalfunctionJan 6, 2026Patient 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 23980273 ↗
• MalfunctionJan 6, 2026Patient 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 23976020 ↗
• MalfunctionJan 6, 2026Patient 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 23974180 ↗
• MalfunctionJan 6, 2026Patient 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 23973915 ↗
• MalfunctionJan 6, 2026Patient 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 23973824 ↗
• MalfunctionOct 21, 2025Packaging Problem; Packaging Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF 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 23350908 ↗
• MalfunctionMay 19, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEVICE FAILED SELF-TEST 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 22046154 ↗
• MalfunctionJan 7, 2025Packaging Problem; Packaging Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THEY HAD EXTREME DIFFICULTY REMOVING THE BACKING FROM PADS DURING OPENING THE PACKAGING, THEY WERE UNABLE TO REMOVE THE BACKING. 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 21091167 ↗
• MalfunctionDec 11, 2024Arcing; Arcing

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), AN ARC WAS SEEN FROM THE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE AND APPLIED A NEW SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 20906135 ↗
• MalfunctionApr 30, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEFIBRILLATOR PROMPTED A "UNIT FAILED" MESSAGE 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 19212319 ↗
• MalfunctionMar 1, 2024Unable 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 DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF DEFIB PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 18816254 ↗
• MalfunctionFeb 29, 2024Arcing of Electrodes; Arcing of Electrodes

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING AN 87-YEAR-OLD FEMALE PATIENT IN CARDIAC ARREST, AN ARC WAS HEARD FROM THE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF DEFIB PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 18806587 ↗
• MalfunctionApr 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 55-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. 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 16785951 ↗
• MalfunctionMar 3, 2023Failure to Analyze Signal; Failure to Analyze Signal

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO ANALYZE. 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 16481023 ↗
• MalfunctionJul 5, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING, CAUSING A DELAY IN THERAPY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 14917552 ↗
• MalfunctionMay 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6)-YEAR-OLD MALE PATIENT, THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING, CAUSING A DELAY IN THERAPY. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE 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 14465361 ↗
• MalfunctionFeb 5, 2021Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A (B)(6) MALE PATIENT, THE ASSOCIATED 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 11289367 ↗
• InjuryMay 1, 2020Arcing of Electrodes; Patient Device Interaction Problem; Arcing of Electrodes; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), AN ARC OCCURRED AT THE ELECTRODE PADS. AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT AND AFTER THE SIXTH DEFIBRILLATION, THE DOCTOR STOPPED THE RESUSCITATION. COMPLAINANT INDICATE THAT THE PATIENT SUSTAINED BURNS, THE DEGREE OF PATIENT BURNS AND ANY ADVERSE EFFECT WAS NOT AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 10018617 ↗
• DeathApr 6, 2020Arcing of Electrodes; Patient Device Interaction Problem; Arcing of Electrodes; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ON THE FOURTH DEFIBRILLATION ATTEMPT ON A PATIENT (AGE & GENDER UNKNOWN), AN ARC WAS HEARD FROM THE ELECTRODE PADS. AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE SET OF ELECTRODE PADS AND OTHER DEFIBRILLATIONS TOOK PLACE, TO CONTINUE TREATING THE PATIENT. THE COMPLAINANT DID NOT INDICATE THE SEVERITY OF THE BURNS SUSTAINED BY THE PATIENT.

  Patient problems: Death; No Information

  MAUDE report 9930483 ↗
• MalfunctionMar 23, 2020Unable 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 ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADS TO CONTINUE TREATING 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 9866226 ↗
• DeathJan 30, 2020Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6)-YEAR-OLD FEMALE PATIENT, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO OBTAIN AN ECG SIGNAL WITH THESE ELECTRODE PADS ATTACHED. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT AND AN ECG SIGNAL WAS OBTAINED. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death

  MAUDE report 9649889 ↗
• MalfunctionDec 26, 2019Unable 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 WITH THESE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 9519681 ↗