CPR-D PADZ 8900-0800-01Recalls & reported problems
Zoll Medical Corporation · CPR-D*PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR HELP · Class 3
All models of CPR-D PADZ (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zoll CPR-D PADZ one-piece electrode pad is used with automated external defibrillators. Most of the 43 reports describe the defibrillator failing to recognize the pads or failing its self-test during routine checks, plus pads that would not stick to a patient's skin. Reports include 2 deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 2
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00847946000189), received between Aug 24, 2015 and Aug 28, 2026 — classified as 2 deaths, 1 injury, 40 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (18 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unable to Obtain Readings18
- Failure of Device to Self-Test8
- Patient Device Interaction Problem7
- Accessory Incompatible3
- Component or Accessory Incompatibility1
- Defective Component1
- Device Difficult to Setup or Prepare1
- Device Displays Incorrect Message1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Patient Involvement9
- No Information4
- Burn(s)1
- Cardiac Arrest1
- Death1
- Insufficient Information1
- Necrosis1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE FAILED SELF TEST USING THESE ELECTRODE PADS.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497964 ↗MalfunctionOct 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT (AGE UNKNOWN), THE ELECTRODE PADS WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Cardiac Arrest
MAUDE report 23403034 ↗MalfunctionOct 15, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIBRILLATOR PROMPTED A "UNIT FAILED" MESSAGE USING THESE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285158 ↗MalfunctionJan 31, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE PROMPTED A "UNIT FAILED" MESSAGE USING THESE CPR-D PADZ. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21284005 ↗MalfunctionDec 12, 2024Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIBRILLATOR DOES NOT RECOGNIZED THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20915749 ↗MalfunctionDec 10, 2024Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE INAPPROPRIATELY DISPLAYED A "PLUG IN CABLE" MESSAGE USING THESE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892321 ↗MalfunctionSep 19, 2024Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THESE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20262395 ↗MalfunctionJun 18, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE ASSOCIATED DEFIBRILLATOR FAILED SELF TEST USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19557080 ↗MalfunctionMay 20, 2024Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIBRILLATOR DISPLAYED A "PLUG IN CABLE" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19351115 ↗MalfunctionApr 3, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A MALE PATIENT (AGE UNKNOWN), THE ELECTRODE PADS WERE DAMAGED DURING REMOVAL FROM THE PACKAGING. 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 19031952 ↗MalfunctionMar 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A 50-60-YEAR-OLD FEMALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. 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 18949295 ↗MalfunctionAug 17, 2023Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17568287 ↗MalfunctionAug 15, 2023Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING INCOMING TESTING, THE ASSOCIATED DEFIBRILLATOR PROMPTED A "PLUG IN CABLE MESSAGE -- INAPPROPRIATE" MESSAGE USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17548178 ↗MalfunctionMay 23, 2023Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THESE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16983841 ↗MalfunctionMar 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A MALE PATIENT (AGE UNKNOWN), THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. 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 16585190 ↗MalfunctionMar 15, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEVICE FAILED SELF TEST USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16547538 ↗MalfunctionMar 2, 2023Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THESE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16473335 ↗MalfunctionDec 13, 2022Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE PROMPTED A "UNIT FAILED" MESSAGE USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15972695 ↗MalfunctionOct 5, 2022Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED SELF TEST USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15545545 ↗MalfunctionOct 5, 2022Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED SELF TEST USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15544966 ↗MalfunctionSep 15, 2022Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THESE ATTACHED ELECTRODES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15432990 ↗InjuryJul 8, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, AN ABRASION WAS FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED BURN MARKS. NO INFORMATION AVAILABLE TO WHAT DEGREE THE BURNS ARE.
Patient problems: Burn(s)
MAUDE report 14959729 ↗MalfunctionJun 30, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), SEVERAL SETS OF ELECTRODE PADS NEEDED TO BE REPLACED DURING THE RESUSITATION DUE TO NOT BEING ABLE TO ADHERE TO THE PATIENT. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 14873670 ↗MalfunctionJun 13, 2022Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14678235 ↗MalfunctionOct 29, 2021Accessory Incompatible; Accessory Incompatible
COMPLAINANT ALLEGED THAT DURING INCOMING TESTING, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO CONNECT TO THE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12723076 ↗
Other Automated external defibrillators (non-wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
- NA 861288Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)21 deaths5,015 reports
- NA 861289Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)7 deaths3,385 reports
- R SERIES 30001005201310012Zoll Medical Corporation · Automated external defibrillators (non-wearable)10 deaths1,720 reports
- PHILIPS HeartStart FRxPhilips Electronics North America Corporation · Automated external defibrillators (non-wearable)26 deaths1,586 reports
- LIFEPAK CR2 99512Physio-Control, Inc. · Automated external defibrillators (non-wearable)8 deaths1,502 reports
- Lifeline Configuration DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 death1,285 reports
- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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