STAT-PADZ 8900-4004Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00847946016456), received between Oct 4, 2017 and Feb 16, 2026 — classified as 1 death, 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 63-YEAR-OLD FEMALE PATIENT WEIGHT 211 POUNDS, 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 24345149 ↗
• MalfunctionJan 23, 2026Device Damaged Prior to Use

  COMPLAINANT ALLEGED THAT WHILE PACING A 60-YEAR-OLD MALE PATIENT, THE ELECTRODE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING. 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: Insufficient Information

  MAUDE report 24162050 ↗
• MalfunctionJan 23, 2026

  AFTER TWO CARDIOVERSION ATTEMPTS ON PATIENT, PADS WERE NOT WORKING AND THEY HAD A BURN SMELL. PADS REMOVED AND NEW PADS WERE CONNECTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160744 ↗
• MalfunctionSep 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), THE ATTACHED ELECTRODE PADS CAME OFF THE PATIENT'S SKIN AFTER ONE CARDIOVERSION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 20200206 ↗
• MalfunctionAug 22, 2024Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEFIBRILLATOR DISPLAYED A "POOR PAD CONTACT" MESSAGE USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED A SECOND SET OF PADS FROM THE SAME LOT NUMBER AND CONTINUED TO GET THE POORR PAD CONTACT MESSAGE. THE CLINICIAN THEN USED PADS FROM A DIFFERENT LOT NUMBER 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 20030067 ↗
• InjuryMay 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Burn(s)

  MAUDE report 16857553 ↗
• InjuryMar 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. 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 16611070 ↗
• MalfunctionJan 11, 2023Accessory Incompatible; Accessory Incompatible

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THESE ELECTRODES PADS WOULD NOT CONNECT TO THE ASSOCIATED DEFIBRILLATOR. 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 16139378 ↗
• InjuryJun 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), AFTER PLACEMENT OF THE ELECTRODE PADS ON THE PATIENT, UPON REMOVAL OF THE PADS, SKIN INTEGRITY ISSUES WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY SUSTAINED A SKIN TEAR. THE SKIN TEAR WAS TREATED WITH PETROLEUM, GAUZE, AND TEGADERM.

  Patient problems: Skin Tears

  MAUDE report 11913293 ↗
• InjuryMar 9, 2021Compatibility Problem; Compatibility Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), UPON REMOVAL OF THE ELECTRODE PADS, TEARING OF THE SKIN WITH SKIN REMOVAL WAS FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED TEARING OF THE SKIN UPON REMOVAL OF THE ELECTRODE PADS.

  Patient problems: Skin Tears

  MAUDE report 11448658 ↗
• InjurySep 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A (B)(6) MALE PATIENT, FOR ABOUT 12 HOURS, AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY SUSTAINED A BURN.

  Patient problems: Burn(s)

  MAUDE report 10600659 ↗
• InjuryMar 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT DID NOT INDICATE THE DEGREE OF THE BURNS FOUND ON THE PATIENT'S SKIN.

  Patient problems: Burn(s)

  MAUDE report 9819313 ↗
• InjuryApr 9, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT, AFTER A 24 HOUR PLACEMENT OF THE ELECTRODE PADS ON THE PATIENT, UPON REMOVAL OF THE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT DID NOT INDICATE IF ADDITIONAL TREATMENT FOR THE BURNS SUSTAINED WERE REQUIRED. PLEASE REFERENCE MEDWATCH REPORT 1220908-2019-00027 AND 1220908-2019-00028 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: Burn(s)

  MAUDE report 8497402 ↗
• InjuryApr 9, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) YEAR OLD FEMALE PATIENT, AFTER A 24 HOUR PLACEMENT OF THE ELECTRODE PADS ON THE PATIENT, UPON REMOVAL OF THE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT DID NOT INDICATE IF ADDITIONAL TREATMENT FOR THE BURNS SUSTAINED WERE REQUIRED. PLEASE REFERENCE MEDWATCH REPORT 1220908-2019-00027 AND 1220908-2019-00029 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: Burn(s)

  MAUDE report 8497393 ↗
• InjuryApr 9, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) YEAR OLD FEMALE PATIENT, AFTER A 24 HOUR PLACEMENT OF THE ELECTRODE PADS ON THE PATIENT, UPON REMOVAL OF THE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT DID NOT INDICATE IF ADDITIONAL TREATMENT FOR THE BURNS SUSTAINED WERE REQUIRED. PLEASE REFERENCE MEDWATCH REPORT 1220908-2019-00028 AND 1220908-2019-00029 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: Burn(s)

  MAUDE report 8497352 ↗
• DeathJan 30, 2018Device Operational Issue; Device Operational Issue

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A FEMALE PATIENT (AGE UNKNOWN) THE ELECTRODE PACKAGING WAS OPENED AND IT WAS DISCOVERED THAT THERE WERE NO ELECTRODES INSIDE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODES TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT DUE TO THE DELAY IN THERAPY, THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death

  MAUDE report 7228292 ↗
• MalfunctionJan 15, 2018Device Operational Issue; Device Operational Issue

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), WHEN REMOVING THE ELECTRODE PADS FROM THE PACKAGING THE GEL ADHERED TO THE PLASTIC PACKAGING. 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 Information

  MAUDE report 7191185 ↗
• MalfunctionOct 4, 2017Incomplete or Missing Packaging; Incomplete or Missing Packaging

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), WHEN THIS SET OF STAT PADS WAS OPENED, THE ELECTRODES WERE MISSING FROM THE PACKAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6914596 ↗