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Kendall 20770Recalls & reported problems

Cardinal Health, Inc. · 20770 Adult Multi-Function Defibrillation Electrodes, Radiotransparent · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884527015617), received between Oct 1, 2020 and Mar 24, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Separation3
  • Fire2

Patient problems

  • No Consequences Or Impact To Patient3
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 24, 2022Fire; Fire

    THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR PADS FOR ZOLL (KENDALL 20770 ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODES) SPARKED A SMALL FLAME WHEN DEFIBRILLATING A PATIENT IN V-FIB IN THE EMERGENCY ROOM. THE PATIENT WAS CONNECTED TO A LUCAS MACHINE WHEN THE EVENT HAPPENED. DEFIBRILLATION APPEARED TO PROPERLY CONDUCT THROUGH PADS BUT ONE OF THE PADS WAS SHORT CIRCUITED AFTER THE EVENT WITH APPARENT BURN MARKS ON SAID PAD. PADS WERE REPLACED ON PATIENT AND NO APPARENT INJURY TO PATIENT WAS NOTED, HOWEVER THE CODE WAS CALLED SHORTLY AFTER EVENT SO IT WAS UNABLE TO BE DETERMINED IF THE PADS CAUSED ANY CHANGE TO PATIENT STATUS. PADS WERE NOTED TO BE PROPERLY SECURED TO THE PATIENT PRIOR TO EVENT AND PLUGGED IN PROPERLY. ZOLL WAS FUNCTIONING PROPERLY AS WELL AND HAD PASSED THE SAFETY CHECKS FOR THE DAY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2022 CONFIRMED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE REPORTED PRODUCT PROBLEM. THE INSTRUCTIONS FOR USE WERE FOLLOWED FOR SKIN PREP. THERE WAS MINIMAL HAIR PER THE STAFF. THE PATIENT WAS DIAPHORETIC BUT STAFF STATED THEY DRIED THE PATIENT OFF. ALONG WITH THE DEFIB, THE PATIENT HAD EKG WIRES, OXYGEN, AND AN ET TUBE. IT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13875707 ↗
  • MalfunctionMar 24, 2022Fire; Fire

    THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR PADS FOR ZOLL (KENDALL 20770 ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODES) SPARKED A SMALL FLAME WHEN DEFIBRILLATING A PATIENT IN V-FIB IN THE EMERGENCY ROOM CAUSING A LUCAS MACHINE OWNED BY AMR TO SHORT CIRCUIT. PADS WERE NOTED TO BE PROPERLY SECURED TO THE PATIENT PRIOR TO EVENT AND PLUGGED IN PROPERLY. ZOLL WAS FUNCTIONING PROPERLY AS WELL AND HAD PASSED THE SAFETY CHECKS FOR THE DAY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 21-MAR-2022 STATED THAT THERE WAS NO PATIENT INJURY OR DEATH. THE INSTRUCTIONS FOR USE WERE FOLLOWED FOR SKIN PREP. IT IS UNKNOWN IF THE ELECTRODE AREA WAS FREE OF HAIR OR DRY. ALONG WITH THE DEFIB, THE PATIENT HAD EKG WIRES, OXYGEN, AND AN ET TUBE. IT IS UNKNOWN HOW MANY SHOCKS THE PATIENT RECEIVED AND UNKNOWN HOW MANY JOULES. IT IS NOT KNOWN WHEN OR WHERE ON THE DEVICE THE SPARK/FLAME OCCURRED. THE FLAME WENT OUT ON IT'S OWN. PATIENT INFORMATION IS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13875593 ↗
  • MalfunctionOct 16, 2020Material Separation; Material Separation

    THE CUSTOMER REPORTED WHEN THEY REMOVE THE DEFIB PATCHES, THE ADHESIVE STAYS BEHIND ON THE PATIENT'S CHEST AND THE CONNECTION CABLES SEEM SHORTER THAN BEFORE. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10689876 ↗
  • MalfunctionOct 16, 2020Material Separation; Material Separation

    THE CUSTOMER REPORTED WHEN THEY REMOVE THE DEFIB PATCHES, THE ADHESIVE STAYS BEHIND ON THE PATIENT'S CHEST AND MAKES A MESS. THEY ALSO REPORTED THE CABLES SEEM SHORTER. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10689609 ↗
  • MalfunctionOct 1, 2020Material Separation; Material Separation

    THE CUSTOMER REPORTED WHEN THEY REMOVE THE DEFIB PADS, THE ADHESIVE STAYED BEHIND ON THE PATIENT'S CHEST AND THE CONNECTION CABLES SEEM SHORTER THAN BEFORE. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10612492 ↗

Other Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.