PRO PADZ 8900-2106-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00847946016401), received between Dec 21, 2017 and May 13, 2025 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Convert Rhythm” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "CHECK PADS" MESSAGE. THE PADS DID NOT SEAT ALL THE WAY TO THE CONNECTOR. THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TO TREAT 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 22010668 ↗
• MalfunctionMay 6, 2025Noise, Audible; Noise, Audible

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), A LOUD POP NOISE WAS HEARD. & #: 8195; 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 21969158 ↗
• InjuryApr 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT AFTER A CARDIOVERSION ON A 63-YEAR-OLD MALE PATIENT, AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. PATIENT SUSTAINED BURN MARKS. THIS IS ALL THE INFORMATION PROVIDED AT THIS TIME.

  Patient problems: Burn(s)

  MAUDE report 19212684 ↗
• MalfunctionMar 8, 2023Patient 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 16501946 ↗
• InjuryJan 24, 2023Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A FEMALE PATIENT (AGE UNKNOWN), A POPPING SOUND WAS HEARD. AFTER REMOVING THE ELECTRODE PADS, A BLISTER WAS 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: Partial thickness (Second Degree) Burn

  MAUDE report 16236994 ↗
• MalfunctionNov 1, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 61-YEAR-OLD FEMALE PATIENT, THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE ELECTRODE PADS. CLINICIANS INDICATED THEY REPOSITIONED THE SAME PADS AND DELIVERED THE SHOCK WITHOUT SYNCHRONIZATION IN MANUAL MODE. 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 15710694 ↗
• MalfunctionJun 9, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 52-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO DEFIBRILLATE EFFECTIVELY. COMPLAINANT INDICATED THAT THE CLINICIAN PERFORMED EXTERNAL CARDIAC MASSAGE 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 14645417 ↗
• MalfunctionApr 13, 2022Failure to Convert Rhythm; Failure to Convert Rhythm

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6)-YEAR-OLD MALE PATIENT, THE ASSOCIATED DEVICE WAS UNABLE TO DEFIBRILLATE EFFECTIVELY. 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 14106592 ↗
• MalfunctionMar 24, 2022Failure to Convert Rhythm; Failure to Convert Rhythm

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT, THE ASSOCIATED DEFIBRILLATOR FAILED TO CARDIOVERT THE PATIENT AFTER THREE SHOCKS WITH ELECTRODE PADS AT 200J. COMPLAINANT INDICATED THAT THE CLINICIAN USED AN INTERNAL DEFIBRILLATOR. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1218058-2022-00023 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 13895009 ↗
• MalfunctionMar 24, 2022Failure to Convert Rhythm; Failure to Convert Rhythm

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6)-YEAR-OLD MALE PATIENT, THE ASSOCIATED DEFIBRILLATOR FAILED TO CARDIOVERT THE PATIENT AFTER TWO SHOCKS WITH ELECTRODE PADS AT 200J. COMPLAINANTS INDICATED THAT THE CLINICIAN PERFORMED AN EXTERNAL CARDIAC MASSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1218058-2022-00024 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 13894384 ↗
• MalfunctionJul 21, 2021Failure to Convert Rhythm; Failure to Convert Rhythm

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT, THE ASSOCIATED DEVICE WOULD NOT CONVERT THE PATIENT'S HEART RHYTHM. THE CLINICIANS OBTAINED ANOTHER DEVICE AND WERE ABLE TO CONVERT THE PATIENT TO A NORMAL SINUS RHYTHM. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1218058-2021-00100 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206856 ↗
• MalfunctionJul 21, 2021Failure to Convert Rhythm; Failure to Convert Rhythm

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT, THE DEVICE WOULD NOT CONVERT THE PATIENT'S HEART RHYTHM. THE CLINICIANS OBTAINED ANOTHER DEVICE AND WERE ABLE TO CONVERT THE PATIENT TO A NORMAL SINUS RHYTHM. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1218058-2021-00099 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206786 ↗
• MalfunctionJan 18, 2021Smoking; Smoking

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), FLAME WAS SEEN COMING FROM THE ELECTRODE PAD. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 11185395 ↗
• MalfunctionDec 31, 2020Compatibility Problem; Output Problem; Compatibility Problem; Output Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S DEFIB OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102270 ↗
• MalfunctionOct 14, 2020Arcing of Electrodes; Arcing of Electrodes

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER 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 Consequences Or Impact To Patient

  MAUDE report 10680245 ↗
• InjuryDec 31, 2019Patient 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. PATIENT SUSTAINED BURNMARKS, NO INFORMATION PROVIDED ON THE DEGREE OF BURN THE PATIENT RECEIVED.

  Patient problems: Burn(s)

  MAUDE report 9535142 ↗
• MalfunctionDec 10, 2019Arcing of Electrodes; Arcing of Electrodes

  COMPLAINANT ALLEGED THAT WHILE CARDIOVERTING A PATIENT (AGE & GENDER UNKNOWN), AN ARC WAS HEARD COMING FROM THE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1218058-2019-00166 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444391 ↗
• MalfunctionDec 10, 2019Sparking; Sparking

  COMPLAINANT ALLEGED THAT WHILE CARDIOVERTING A PATIENT (AGE & GENDER UNKNOWN), SPARKING WAS SEEN COMING FROM THE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1218058-2019-00167 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444379 ↗
• MalfunctionDec 21, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT, THE ELECTRODE PADS 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. PLEASE REFERENCE MEDWATCH REPORT 1218058-2017-00139, 1218058-2017-00140, AND 1218058-2017-00142 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Information

  MAUDE report 7139710 ↗
• MalfunctionDec 21, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT, THE ELECTRODE PADS 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. PLEASE REFERENCE MEDWATCH REPORT 1218058-2017-00139, 1218058-2017-00140, AND 1218058-2017-00141 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Information

  MAUDE report 7138171 ↗
• MalfunctionDec 21, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT, THE ELECTRODE PADS WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED TWO MORE SETS OF ELECTRODE PADS, SAME LOT NUMBER 3617, WITH THE SAME RESULT AS THE FIRST SET. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORTS 1218058-2017-00139, 1218058-2017-00141, AND 1218058-2017-00142, FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Information

  MAUDE report 7137462 ↗
• MalfunctionDec 21, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PATIENT, THE FIRST AND SECOND SETS OF ELECTRODE PADS WOULD NOT ADHERE TO THE PATIENT'S SKIN. THE COMPLAINANT INDICTED THE THIRD SET OF ELECTRODE PADS DID ADHERE TO THE PATIENT AND THEY CONTINUED TO TREAT THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1218058-2017-00140, 1218058-2017-00141, AND 1218058-2017-00142 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Information

  MAUDE report 7137457 ↗