PRO PADZ 8900-4006 (UDI 00847946016661)Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 00847946016661), received between Nov 18, 2017 and Jul 6, 2026 — classified as 73 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (67 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 145 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN); AFTER REMOVING THE ELECTRODE PADS, A SKIN BLISTER/TEAR WAS FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED A STERNAL SKIN TEAR. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25718134 ↗
• InjuryMay 13, 2026Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE AND AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 25161964 ↗
• InjuryMay 13, 2026Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE AND GENDER UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE AND AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 25161957 ↗
• InjuryMay 13, 2026Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE CARDIOVERTING A MALE PATIENT (AGE UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE AND AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 25161143 ↗
• InjuryMay 13, 2026Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE AND GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS.

  Patient problems: Burn(s)

  MAUDE report 25161137 ↗
• InjuryMay 13, 2026Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A FEMALE PATIENT (AGE UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS. MEDSUN REPORT #: (B)(4).

  Patient problems: Burn(s)

  MAUDE report 25161123 ↗
• InjuryMay 13, 2026Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Burn(s)

  MAUDE report 25161042 ↗
• InjuryMay 13, 2026Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Burn(s)

  MAUDE report 25161013 ↗
• InjuryMay 13, 2026Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS.

  Patient problems: Burn(s)

  MAUDE report 25159716 ↗
• InjuryMay 12, 2026Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE AND AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 25148757 ↗
• MalfunctionMay 11, 2026Sparking

  COMPLAINANT ALLEGED THAT WHILE CARDIOVERTING A MALE PATIENT (AGE UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 25135140 ↗
• MalfunctionMay 7, 2026Sparking

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN), AN ARC WAS HEARD FROM THE 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 25111416 ↗
• MalfunctionApr 29, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 21-YEAR-OLD MALE PATIENT, 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 25027769 ↗
• MalfunctionApr 16, 2026Sparking

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 69-YEAR-OLD MALE PATIENT, A SPARK WAS EMITTED FROM THE PADS.

  Patient problems: Insufficient Information

  MAUDE report 24897493 ↗
• MalfunctionMar 31, 2026Sparking

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED MINOR SKIN BURNS.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24746833 ↗
• MalfunctionMar 9, 2026Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), AFTER DISCHARGE A POPPING NOISE WAS HEARD AND THE PADS WERE REMOVED AND NOTED A BURN ON THE PATIENT'S LEFT TORSO. THE DEGREE OF BURN WAS NOT PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 24551383 ↗
• MalfunctionMar 5, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA 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 24519733 ↗
• MalfunctionFeb 2, 2026

  PATIENT IN FOR AN ELECTIVE CARDIOVERSION. PATIENT SHAVED PREPPED AND DRIED, GOOD ADHESION WITH PADS TO SKIN. THE PATIENT WAS SHOCKED USING EXTERNAL SYNCHRONIZED BIPHASIC SHOCK WITH 200 JOULES. A SPARK WAS NOTED BY STAFF DURING BIPHASIC SHOCK AT THE ANTERIOR DEFIB PAD LOCATION AND PADS IMMEDIATELY REMOVED, BURNED HAIR AND POSSIBLE 1ST DEGREE BURN AT SITE OF ANTERIOR PAD. THE SHOCK WAS SUCCESSFUL, MD EVALUATED SITE, PATIENT RECOVERED AND DISCHARGED HOME LATER SAME DAY.

  Patient problems: Shock from Patient Lead(s); Superficial (First Degree) Burn

  MAUDE report 24230467 ↗
• InjuryNov 25, 2025Sparking; Sparking

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A 87-YEAR-OLD MALE PATIENT, SPARKS WERE EMITTED FROM THE ELECTRODE PADS LEAVING BURNS ON THE PATIENT. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Burn(s)

  MAUDE report 23645744 ↗
• MalfunctionJun 24, 2025Sparking; Sparking

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A MALE PATIENT (AGE UNKNOWN), THE ELECTRODE PADS SPARKED BURNING THE PATIENT. THE PATIENT'S SKIN IS RED BUT NOT BLISTERED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Burn(s)

  MAUDE report 22319454 ↗
• MalfunctionJun 24, 2025Sparking; Patient Device Interaction Problem; Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT AN 80-YEAR-OLD MALE PATIENT, SPARKS WERE EMITTED FROM THE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED A FIRST-DEGREE BURN AND WERE TREATED WITH A TOPICAL OINTMENT.

  Patient problems: Burn(s)

  MAUDE report 22319081 ↗
• MalfunctionMay 14, 2025Sparking; Sparking

  COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A 96-YEAR-OLD, MALE PATIENT, THE ANTERIOR DEFIBRILLATOR PAD SPARKED. 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 22022184 ↗
• MalfunctionApr 24, 2025Sparking; Patient Device Interaction Problem

  PATIENT WAS HERE FOR A SCHEDULED CARDIOVERSION. WHEN THE SHOCK BUTTON WAS PUSHED THE ANTERIOR DEFIBRILLATOR PAD SPARKED. THE PATIENT RECEIVED A MINOR BURN. HE DENIED PAIN TO STAFF, BURN REQUIRED NO TREATMENT, AND PATIENT WAS DISCHARGED HOME A FEW HOURS LATER. ZOLL MACHINE WENT TO BIOMED WHO FOUND NO ISSUES WITH THE MACHINE AND RETURNED IT TO SERVICE. PICTURE OF PAD PACKAGE WAS TAKEN BUT ACTUAL PADS WERE DISCARDED AT THE TIME OF THE EVENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21900731 ↗
• InjuryMar 4, 2025Sparking; Patient Device Interaction Problem; Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), THERE WAS A SPARK SEEN FROM THE ELECTRODE PADS AND AFTER REMOVING THE ELECTRODE PADS, BURNS OF AN UNKNOWN DEGREE WERE FOUND ON THE PATIENT. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1218058-2025-00032 AND 1218058-2025-00034 FOR SIMILAR REPORTS FROM THE SAME CUSTOMER.

  Patient problems: Burn(s)

  MAUDE report 21515723 ↗
• InjuryMar 4, 2025Sparking; Patient Device Interaction Problem; Sparking; Patient Device Interaction Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), THERE WAS A SPARK SEEN FROM THE ELECTRODE PADS AND AFTER REMOVING THE ELECTRODE PADS, BURNS OF AN UNKNOWN DEGREE WERE FOUND ON THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1218058-2025-00032 AND 1218058-2025-00035 FOR SIMILAR REPORTS FROM THE SAME CUSTOMER.

  Patient problems: Burn(s)

  MAUDE report 21515631 ↗