PadPro 2602ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10653405042549), received between Nov 7, 2017 and Feb 8, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Analyze Signal” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K002280, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2018Failure to Sense; Failure to Sense

  THE USER FACILITY REPORTED THAT DURING SET UP FOR MONITORING AND POTENTIAL DEFIBRILLATION, THE 2602Z MINI PEDIATRIC PAD WAS NOT PROVIDING A STABLE READING. THE PAD WAS NOT ABLE TO ANALYZE OR DELIVER DEFIBRILLATION IF NEEDED DUE TO THE UNSTABLE READING. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO RECEIVE THE NEEDED TREATMENT. ADDITIONAL INFORMATION REGARDING THE DELAY FOR TREATMENT AND CHANGE IN THE PATIENT'S CONDITION DURING THAT TIME HAS NOT BEEN PROVIDED. THE PATIENT WAS REPORTED TO BE STABLE POST RECEIVING TREATMENT. THIS REPORT IS RAISED ON THE BASIS OF A POTENTIALLY LIFE-THREATENING EVENT DUE TO A REPORTED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7253242 ↗
• MalfunctionNov 7, 2017Failure to Analyze Signal; Failure to Analyze Signal

  THE USER FACILITY THAT THE PADPRO PADS FAILED TESTING. THE PADS WERE USED ON A VARIETY OF PATIENTS; IMPEDANCE AND TROUBLESHOOTING WERE PERFORMED AS WELL, BUT THE PADS DID NOT FUNCTION AS INTENDED. THIS INCIDENT IS NOT ASSOCIATED WITH ONE PATIENT OR EVENT. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7006879 ↗
• MalfunctionNov 7, 2017Failure to Analyze Signal; Failure to Analyze Signal

  A CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT THE PADPRO PADS FAILED TESTING. THE PADS WERE USED ON A VARIETY OF PATIENTS; IMPEDANCE AND TROUBLESHOOTING WERE PERFORMED AS WELL, BUT THE PADS DID NOT FUNCTION AS INTENDED. THIS INCIDENT IS NOT ASSOCIATED WITH ONE PATIENT OR EVENT. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7006873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002280, P200004. One submission often covers many models, so check the product and lot details in each record.

• Z-1176-2018 · Feb 23, 2018 · Terminated
  MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applicat
• Z-1175-2018 · Feb 23, 2018 · Terminated
  MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applicat
• Z-1177-2018 · Feb 23, 2018 · Terminated
  MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring
• Z-1178-2018 · Feb 23, 2018 · Terminated
  MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-
• Z-1174-2018 · Feb 23, 2018 · Terminated
  MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applicatio
• Z-0460-2015 · Nov 6, 2014 · Terminated
  MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during d