PadProRecalls & reported problems across all models

We found 13 models of PadPro by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Jan 27, 2016 and Jun 29, 2026 — classified as 4 deaths, 9 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PadPro problems

PadPro models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PadPro 2001Z-C

  Automated External Defibrillators (Non-Wearable)
  1 death12 reports
• PadPro 2001M-C

  Automated External Defibrillators (Non-Wearable)
  1 death9 reports
• PadPro 2001M

  Automated External Defibrillators (Non-Wearable)
  7 reports
• PadPro 2516M

  Automated External Defibrillators (Non-Wearable)
  6 reports
• PadPro 2001M-PC

  Automated External Defibrillators (Non-Wearable)
  1 death4 reports
• PadPro 2602Z

  Automated External Defibrillators (Non-Wearable)
  3 reports
• PadPro 2001Z-PC

  Automated External Defibrillators (Non-Wearable)
  2 reports
• PadPro 2516M-PC

  Automated External Defibrillators (Non-Wearable)
  2 reports
• PadPro 2001H

  Automated External Defibrillators (Non-Wearable)
  2 reports
• PadPro 2001H-C

  Automated External Defibrillators (Non-Wearable)
  2 reports
• PadPro 2001

  Automated External Defibrillators (Non-Wearable)
  1 report
• PadPro 2001Z

  Automated External Defibrillators (Non-Wearable)
  1 death1 report
• PadPro 2516Z

  Automated External Defibrillators (Non-Wearable)
  1 report

Recent PadPro adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Insufficient Device Problem Information

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M ADULT/CHILD=10KG RADIOTRANS ELECTRD,PHYSIOCONTROLQUIKCOMBODEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A HEMODYNAMICS PROCEDURE WHEN IT WAS REPORTED ¿BURN OCCURS IMMEDIATELY AFTER THE FIRST SHOCK.¿. FURTHER ASSESSMENT FOUND THAT THE PATIENT EXPERIENCED A 1ST DEGREE BURN AND IT WAS TREATED WITH TROLAMINE LOCATED ON THE ANTERIOR CHEST. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 25649934 ↗
• InjuryJun 29, 2026Insufficient Device Problem Information

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M ADULT/CHILD=10KG RADIOTRANS ELECTRD,PHYSIOCONTROLQUIKCOMBODEVICE WAS BEING USED ON (B)(6) 2026 DURING A HEMODYNAMICS PROCEDURE WHEN IT WAS REPORTED "ANOTHER INCIDENT HAPPENED WITH THE SAME BATCH OF PADPRO UNITS, A BURN OCCURS IMMEDIATELY AFTER THE FIRST SHOCK AT 200 J. ADDITIONALLY, A DIFFERENT DEFIBRILLATOR WAS USED AND THE ISSUE STILL OCCURRED." FURTHER ASSESSMENT FOUND THAT THE PATIENT EXPERIENCED A 2ND DEGREE BURN AND IT WAS TREATED WITH GRADE 2 DRESSING WITH GREASY GAUZE LOCATED ON THE ANTERIOR CHEST. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT EXPERIENCING A 2ND DEGREE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25649880 ↗
• MalfunctionMar 31, 2026Insufficient Device Problem Information

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M ADULT/CHILD=10KG RADIOTRANS ELECTRD,PHYSIOCONTROLQUIKCOMBO DEVICE WAS BEING USED DURING A HEMODYNAMICS PROCEDURE ON (B)(6) 26 WHEN IT WAS REPORTED ¿THE APPLICATION OF SHOCK IN SYNCHRONIZED CARDIOVERSIONS, WITH MAXIMUM ENERGY OF 360 J, IN AF, LEAVES BURNS ON THE PATIENT¿S CHEST (THE OUTER EDGE). IT IS NECESSARY TO CONFIRM THE CHARACTERISTICS AND GEL OF THE ELECTRODES.¿. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS COMPLETED WITH NO INFORMATION FOUND. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE PATIENT OBTAINING AN UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 24740549 ↗
• DeathFeb 20, 2026Insufficient Device Problem Information

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 2001Z, ADULT/CHILD = 10 KG RADIOTRANSPARENT ELECTRODE,ZOLL DEVICE WAS USED DURING A CARDIAC ARREST ON 30JAN26 AND ¿PAD PRO USED TO RESUSCITATE PATIENT, ERROR CAME UP ON ZOLL UNIT. UNABLE TO RECTIFY ISSUE. PADS WERE CHANGED FOR A DIFFERENT LOT AND RESUSCITATION WAS COMPLETED SUCCESSFULLY.". THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Cardiac Arrest

  MAUDE report 24399923 ↗
• MalfunctionJan 28, 2026Failure to Conduct

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 2516M-PC DEFIB ELECTRODE ADULT, RADIOTRANS PADS W/PRECONNECT, MEDTRONIC, DEVICE WAS BEING USED ON (B)(6) 2026 WHEN IT WAS REPORTED WAS REPORTED ¿A PATIENT WHO WENT INTO RESUSCITATION AND HAD TO BE GIVEN AN ELECTRIC SHOCK. THE PATIENT REQUIRED ELECTRICAL DEFIBRILLATION; THEREFORE, DEFIBRILLATOR PADS WERE APPLIED. PADPRO PADS WERE APPLIED TO THE PATIENT, AND A MEDTRONIC DEFIBRILLATOR WAS CONNECTED. THE PADPRO DID NOT TRANSMIT AND DID NOT FUNCTION. TWO ADDITIONAL DEFIBRILLATORS WERE USED, HOWEVER THE PADPRO STILL DID NOT FUNCTION. EVENTUALLY, THE DEFIBRILLATOR PADS WERE REPLACED WITH A NEW PADPRO SET. AFTER REPLACING THE PADS, DEFIBRILLATION WAS POSSIBLE AND THE PADS FUNCTIONED PROPERLY. NO HARM WAS CAUSED TO THE PATIENT.¿ THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202518 ↗
• MalfunctionJan 7, 2026Defibrillation/Stimulation Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 2001M, ADULT/CHILD=10KG RADIOTRANS ELECTRD, PHYSIOCONTROLQUIKCOMB, WAS BEING USED DURING A DEFIB PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE CATH LAB HAS EXPRESSED CONCERNS ABOUT THE FORMULARY CHANGE TO THE DEFIB PADS. WHERE (NAME) WAS IN THE ROOM AND THE PATIENT WENT INTO VTACH, AND SHE WALKED OVER TO SHOCK THE PATIENT, AND THE DEFIB PAD WASN¿T CAPTURING. SHE THEN LOOKED AT THE PATIENT¿S CHEST AND THE DEFIB PADS WERE CURLING AND NOT ADHERING TO THE SKIN. THE SITUATION WAS RESOLVED WHEN (DOCTOR) PULLED THE WIRE FOR THE DEFIB PAD, BUT HAD HE NOT DONE THAT, THE STAFF WOULD¿VE HAD TO HOLD THE PADS DOWN TO THE SKIN WHILE SHOCKING THE PATIENT POTENTIALLY CAUSING INJURY TO THE STAFF AND DELAYED CARE TO THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FROM THE REPORTER FOUND, ¿THE ISSUE FROM THIS PARTICULAR FACILITY IS ADHESION RELATED, PEELING UP ON THE EDGES WHICH CAUSES POOR PAD TO PATIENT CONTACT. THIS SYSTEM DOES PLACE THE PADS UNDERNEATH A BAIR HUGGER PRIOR TO PLACING THEM ON PATIENTS TO WARM THEM UP. LEADERSHIP FROM (FACILITY)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988337 ↗
• MalfunctionJan 7, 2026Defibrillation/Stimulation Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 2001M, ADULT/CHILD=10KG RADIOTRANS ELECTRD, PHYSIOCONTROLQUIKCOMB, WAS BEING USED DURING A DEFIB PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE CATH LAB HAS EXPRESSED CONCERNS ABOUT THE FORMULARY CHANGE TO THE DEFIB PADS. WHERE (NAME) WAS IN THE ROOM AND THE PATIENT WENT INTO VTACH, AND SHE WALKED OVER TO SHOCK THE PATIENT, AND THE DEFIB PAD WASN¿T CAPTURING. SHE THEN LOOKED AT THE PATIENT¿S CHEST AND THE DEFIB PADS WERE CURLING AND NOT ADHERING TO THE SKIN. THE SITUATION WAS RESOLVED WHEN (DOCTOR) PULLED THE WIRE FOR THE DEFIB PAD, BUT HAD HE NOT DONE THAT, THE STAFF WOULD¿VE HAD TO HOLD THE PADS DOWN TO THE SKIN WHILE SHOCKING THE PATIENT POTENTIALLY CAUSING INJURY TO THE STAFF AND DELAYED CARE TO THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FROM THE REPORTER FOUND, ¿THE ISSUE FROM THIS PARTICULAR FACILITY IS ADHESION RELATED, PEELING UP ON THE EDGES WHICH CAUSES POOR PAD TO PATIENT CONTACT. THIS SYSTEM DOES PLACE THE PADS UNDERNEATH A BAIR HUGGER PRIOR TO PLACING THEM ON PATIENTS TO WARM THEM UP. LEADERSHIP FROM (FACILITY)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988336 ↗
• MalfunctionDec 22, 2025Noise, Audible

  AFTER ANESTHESIA PROVIDED SEDATION; 200 J OF SYNCHRONIZED ENERGY USED, AND A SMALL POP OCCURRED AT THE SITE OF THE PAD. SO, WE CHANGED THE PADS AND REPEATED THE CARDIOVERSION WITH 200 J AND PRESSURE, AND PATIENT CONVERTED TO SINUS RHYTHM. THE PADS WERE REMOVED THERE DOES NOT APPEAR TO BE ANY BURN MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862775 ↗
• MalfunctionDec 17, 2025Failure to Conduct; Failure to Conduct

  THE CUSTOMER REPORTED THAT THE THAT THE 2001M ADULT/CHILD=10KG RADIOTRANS ELECTRODE,PHYSIO CONTROL QUIK COMBO DEVICE WAS BEING USED DURING A VENTRICULAR FIBRILLATION ABLATION ON (B)(6) 2025 WHEN IT WAS REPORTED ¿ENERGY IS COMING THROUGH BUT NOT CONVERTING THE PATIENTS. THE FIRST INCIDENT WAS ON (B)(6) 25 DURING A VENTRICULAR FIBRILLATION ABLATION; ONCE THE HANDS-OFF PADS DID NOT WORK THE RN USED THE MANUAL PADDLES TO DEFIBRILLATE THE PATIENT OUT OF VT. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826991 ↗
• MalfunctionSep 29, 2025Failure to Read Input Signal; Failure to Read Input Signal

  A CUSTOMER REPORTED THAT THE 2001Z-C, ADULT/CHILD = 10 KG RADIOTRANSPARENT ELECTRODE, ZOLL DEVICE WAS USED IN A CARDIOVERSION PROCEDURE ON (B)(6) 2025, AND ¿IN THE EMERGENCY ROOM THE PATIENT RECEIVED A CARDIOVERSION. NEEDED TO SWITCH OUT PADS TO COMPLETE PROCEDURE. PAT REMAINED 5 ADDITIONAL DAYS IN HOSPITAL. DELAYED PUSHING MEDS, PATIENT CARE, AND CARDIOVERSION. NO DIRECT INJURY OR ADVERSE EFFECT OF PADS. PT STAYED AS AN INPATIENT FOR 6 DAYS AFTER RECEIVEING THE CARDIOVERSION, THEN LEFT HEART CATH, THEN PPM IMPLANTATION¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH A DELAY OF 3 TO 5 MINUTES. FURTHER ASSESSMENT FOUND THE "PADS WERE NOT READING A RHYTHM" AND "WHEN THE PADS WERE NOT READING THE RHYTHM, THEY WERE NOT USED FOR SHOCKING THE PATIENT- THEY WERE REMOVED AND A NEW SET WAS USED.". THIS WAS THE FIRST APPLICATION OF THE PADS AND THEY WERE FULLY ADHERENT TO THE PATIENT'S SKIN. THE PATIENT¿S STATUS IS REPORTED AS ¿DISCHARGED FROM INPATIENT STATUS.¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23165345 ↗
• DeathSep 15, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEVICE, 2001M-C, ADULT/CHILD: 10KG. RADIOTRANELECTRODE, PHYSIOCONTROLQUIKCOMBO, WAS BEING USED DURING A RESUSCITATION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DEFIBRILLATOR PADS BURNED/SMOKING. SCALDED PATIENT AND FAILED TO DEFIBRILLATE. REPLACED PADS AND FUNCTIONED CORRECTLY. 2 LOTS USED, UNSURE AS TO WHICH LOT HAD ISSUE. PATIENT STATUS DECEASED.¿. FURTHER ASSESSMENT FOUND THAT THIS WAS A RESUSCITATION EVENT. THE BURN WAS DISCOVERED IMMEDIATELY AFTER PULLING BACK THE GOWN DURING THE EVENT. THE BURN WAS NOT EVALUATED AS THE PATIENT WAS DECEASED. THE BURN OCCURRED ON THE CHEST/UPPER ABDOMEN. THE REPORTER HAS STATED THAT AFTER DEFIBRILLATION "WE HAD RETURN OF SPONTANEOUS CIRCULATION BRIEFLY." AS FOR A CONNECTION BETWEEN DEVICE AND PATIENT DEATH, REPORTER STATED THEY ARE "UNSURE" AND ADDED, "WE WERE UNABLE TO RESUSCITATE THIS PATIENT IN A TIMELY MANNER. THE PATIENT WAS IN A SHOCKABLE ARRHYTHMIA, HENCE WHY DEFIBRILLATION WAS USED. IF WE WOULD HAVE BEEN ABLE TO SHOCK THE PATIENT OUT OF THE RHYTHM SOONER, IT MAY HAVE CHANGED THE OUTCOME OF THE RESUSCITATION EVENT, BUT THAT IS SPECULATIVE, AND I CANNOT SPECIFICALLY SAY THAT THIS WOULD HAVE CHANGED THE

  Patient problems: Arrhythmia; Burn(s)

  MAUDE report 23053740 ↗
• MalfunctionAug 27, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEVICE, 2001Z-C, ADULT/CHILD = 10 KG RADIOTRANSPARENT ELECTRODE, ZOLL, WAS BEING USED DURING A TRANSCUTANEOUS PACING PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿ZOLL DEFIBRILLATOR FAILED TO TRANSCUTANEOUSLY PACE IN 3 INSTANCES, (LOCATION). ONLY CONNECTION DISCOVERED SO FAR IS SAME LOT NUMBER FOR DEFIB PADS¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION OF THE PATIENT. WHEN ASKED THE REPORTER GAVE FURTHER INFORMATION STATING, "I WOULD SAY IT WAS A NORMAL CASE THAT TURNED INTO AN EMERGENCY. WE HAVE THEM ON ¿JUST IN CASE¿ AND THEN, WHEN WE NEED THEM, THEY ARE THERE. SO, IN OUR CASE, WE DID A NORMAL OUTPATIENT AND WHEN WE NEEDED THEM AS A BACK UP, THAT IS WHEN IT FAILED." THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902179 ↗
• MalfunctionAug 27, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEVICE, 2001Z-C, ADULT/CHILD = 10 KG RADIOTRANSPARENT ELECTRODE, ZOLL, WAS BEING USED DURING A TRANSCUTANEOUS PACING PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿ZOLL DEFIBRILLATOR FAILED TO TRANSCUTANEOUSLY PACE IN 3 INSTANCES, (LOCATION). ONLY CONNECTION DISCOVERED SO FAR IS SAME LOT NUMBER FOR DEFIB PADS¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION OF THE PATIENT. WHEN ASKED THE REPORTER GAVE FURTHER INFORMATION STATING, "I WOULD SAY IT WAS A NORMAL CASE THAT TURNED INTO AN EMERGENCY. WE HAVE THEM ON ¿JUST IN CASE¿ AND THEN, WHEN WE NEED THEM, THEY ARE THERE. SO, IN OUR CASE, WE DID A NORMAL OUTPATIENT AND WHEN WE NEEDED THEM AS A BACK UP, THAT IS WHEN IT FAILED." THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902177 ↗
• MalfunctionAug 27, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEVICE, 2001Z-C, ADULT/CHILD = 10 KG RADIOTRANSPARENT ELECTRODE, ZOLL, WAS BEING USED DURING A TRANSCUTANEOUS PACING PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿ZOLL DEFIBRILLATOR FAILED TO TRANSCUTANEOUSLY PACE IN 3 INSTANCES, (LOCATION). ONLY CONNECTION DISCOVERED SO FAR IS SAME LOT NUMBER FOR DEFIB PADS¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION OF THE PATIENT. WHEN ASKED THE REPORTER GAVE FURTHER INFORMATION STATING, "I WOULD SAY IT WAS A NORMAL CASE THAT TURNED INTO AN EMERGENCY. WE HAVE THEM ON ¿JUST IN CASE¿ AND THEN, WHEN WE NEED THEM, THEY ARE THERE. SO, IN OUR CASE, WE DID A NORMAL OUTPATIENT AND WHEN WE NEEDED THEM AS A BACK UP, THAT IS WHEN IT FAILED." THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902176 ↗
• MalfunctionFeb 21, 2025Arcing; Arcing

  THE CUSTOMER REPORTED THAT THE 2001Z-PC, ADULT/CHILD =10 KG RADIOTRANSPARENT ELECTRODE, LOT NUMBER Y09032401 WAS BEING USED ON (B)(6) 2025 DURING A CARDOIVERSION PROCEDURE WHEN IT WAS REPORTED ¿AN ARC OCCURRED DURING CARDIOVERSION USING THE PADPRO 2001Z-PC...ONE HAD A SUPERFICIAL BURN.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21433156 ↗

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