PadPro 2001M-PCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10653405042594), received between Jul 30, 2019 and Mar 31, 2023 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fire” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K014209, P200004); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Fire; Fire

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M-PC, PADPRO:AD;RTRANS EL/LW,PRE-CON WAS USED DURING A CODE SITUATION IN CVICU ON THE DATE OF (B)(6) 2023, WHEN IT WAS REPORTED, ¿ WE HAD AN ISSUE OVER THE WEEKEND WITH SOME 2001M-PC DEFIB PADS CATCHING FIRE. IT WAS IN THE CVICU DEPARTMENT - IN THE MIDDLE OF CODE, THE PAD SPARKED, POPPED, AND PRODUCED A SMALL FLAME AND THEN WENT OUT. BIO MED IS CHECKING HEAD BOX TO ISSUES AS WELL. THEY DON¿T HAVE THE AFFECTED PADS. (REPORTER) ASKED THE NURSE IF CHLORAPREP HAD BEEN USED. THE NURSE WAS ABLE TO CONFIRM IF THAT WAS THE CASE OR NOT.¿. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO PATIENT OR USER INJURY, PROLONGED HOSPITALIZATION, OR MEDICAL INTERVENTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Insufficient Information

  MAUDE report 16657318 ↗
• MalfunctionMar 31, 2023Fire; Fire

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M-PC, PADPRO:AD;RTRANS EL/LW,PRE-CON WAS USED DURING A CODE SITUATION IN CVICU ON THE DATE OF (B)(6) 2023, WHEN IT WAS REPORTED, ¿ WE HAD AN ISSUE OVER THE WEEKEND WITH SOME 2001M-PC DEFIB PADS CATCHING FIRE. IT WAS IN THE CVICU DEPARTMENT - IN THE MIDDLE OF CODE, THE PAD SPARKED, POPPED, AND PRODUCED A SMALL FLAME AND THEN WENT OUT. BIO MED IS CHECKING HEAD BOX TO ISSUES AS WELL. THEY DON¿T HAVE THE AFFECTED PADS. (REPORTER) ASKED THE NURSE IF CHLORAPREP HAD BEEN USED. THE NURSE WAS ABLE TO CONFIRM IF THAT WAS THE CASE OR NOT.¿. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO PATIENT OR USER INJURY, PROLONGED HOSPITALIZATION, OR MEDICAL INTERVENTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Insufficient Information

  MAUDE report 16657260 ↗
• InjuryAug 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M-PC, PADPRO:AD;RTRANS EL/LW,PRE-CON, QUANTITY OF 3, WERE BEING USED DURING A DEFIBRILLATION DUE TO CARDIAC ARREST ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿THE PADPRO ELECTRODES DID NOT STICK PROPERLY TO THE PATIENT, WHY THEY HAD TO BE CHANGED SEVERAL TIMES AND DELAYED THE DEFIB.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT 3 PADS WERE USED ON THE SAME PATIENT. THERE WAS NO REPORT OF INJURY OR PROLONGED HOSPITALIZATION FOR THE PATIENT; HOWEVER, THE USER DID REPORT THAT THE SCENARIO WAS ¿LIFE THREATENING¿ BECAUSE THE PADS DID NOT WORK DURING A CARDIAC ARREST DEFIBRILLATION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO REPORT OF LIFE-THREATENING SCENARIO WHERE PADS DID NOT STICK TO PATIENT DURING USE.

  Patient problems: Cardiac Arrest

  MAUDE report 15321192 ↗
• DeathJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE PADPRO 2001M-PC, WAS USED ON A PATIENT THAT EVENTUALLY PASSED AWAY. THE PADS WERE PLACED ON THE PATIENT BUT NEVER USED TO DELIVER SHOCK. THE PATIENT UNDERWENT 2 SEPARATE ROUNDS OF CPR, THE FIRST LASTED FOR 30 MINUTES AND THE SECOND LASTED FOR 45 MINUTES. THE PADS WERE NEVER USED TO DELIVER SHOCK TO THE PATIENT, THEY WERE ONLY APPLIED FOR MONITORING. AFTER THE PATIENT EXPIRED, THE PADS WERE REMOVED AND UNDER THE STERNAL PAD, WHICH THE MEDICAL STAFF PERFORMED CPR ON TOP OF, A SEVERE SKIN TEAR WAS NOTICED. NO TREATMENT WAS USED SINCE THE PATIENT PASSED AWAY. THE COMPLAINANT DID STATE THAT THE PADPRO DEFIBRILLATION PADS IN NO WAY EFFECTED THE OUTCOME OF THE PATIENT OR HAD ANY EFFECT ON THE PATIENT PASSING AWAY. ALTHOUGH THE PADPRO PADS WERE NOT RELATED TO THE PATIENT EXPIRING, CONMED IS REPORTING DUE TO THE PATIENT HAVING THE PADPRO DEFIBRILATION PADS APPLIED, THEN REMOVED POST-MORTEM.

  Patient problems: Death

  MAUDE report 8841973 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014209, P200004. One submission often covers many models, so check the product and lot details in each record.

• Z-0456-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
• Z-0455-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
• Z-0454-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillat
• Z-1317-2013 · May 3, 2013 · Terminated
  PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtro