PRO PADZ 8900-2302-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847946016418), received between Jun 6, 2018 and Sep 22, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2025Failure to Capture; Failure to Capture

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A MALE PATIENT (AGE UNKNOWN), THE DEVICE FAILED TO CAPTURE THE PATIENT'S HEART RHYTHM. 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 23112104 ↗
• MalfunctionApr 1, 2022Arcing of Electrodes; Noise, Audible; Arcing of Electrodes; Noise, Audible

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), AN ARC WAS SEEN FROM THE ELECTRODE PADS AND A LOUD POP NOISE WAS HEARD. 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 13979372 ↗
• MalfunctionFeb 14, 2022Use of Device Problem; Use of Device Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), TWO SETS OF ELECTRODE PADS NEEDED TO BE REPLACED DURING CHEST COMPRESSIONS, CAUSING UNNECESSARY DELAYS IN DELIVERING THERAPY. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED A SET OF PADDLES 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 13525218 ↗
• MalfunctionAug 23, 2021Sparking; Sparking

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A MID-70'S-YEAR-OLD MALE PATIENT, A RED GLOW (SPARK) WAS SEEN COMING FROM THE ATTACHED 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 12355903 ↗
• MalfunctionAug 14, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODES 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 8895028 ↗
• MalfunctionJun 6, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE DISPLAYED A "CHECK PADS" MESSAGE USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED SEVERAL SETS OF ELECTRODE PADS (ONE SAME LOT 1518 AND ONE DIFFERENT LOT 1218 - MANUFACTURE DATE OF 3/19/2018 EXPIRATION DATE OF 12/19/2019) TO CONTINUE TREATING THE PATIENT AND THE "CHECK PADS" MESSAGE APPEARED. THE COMPLAINANT INDICATED THAT THIS CAUSED A DELAY IN THE TREATMENT OF 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 7574034 ↗