R SERIES 30001001001110012Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN,MAN-1,3/5 LD,STD ECG,AC PWR,SPO2,W/PACE,ADVISORY,CF/USB, ENG · Class 3

All models of R SERIES (94)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Zoll R Series is an automated external defibrillator. Many of the 135 reports describe the screen going blank, the device failing to power up or self-test, and trouble getting heart readings, and 96 list no clinical signs or conditions. The reports include 1 death and 2 injuries. 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: 136
Deaths reported: 1
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 00847946017279), received between Apr 17, 2017 and Sep 8, 2026 — classified as 1 death, 2 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (29 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Defibrillation/Stimulation Problem29
No Display/Image29
Unable to Obtain Readings18
Failure to Power Up17
Pacing Problem15
Failure of Device to Self-Test9
Failure to Deliver Shock/Stimulation8
Failure to Charge5

Patient problems

No Clinical Signs, Symptoms or Conditions97
No Patient Involvement27
Insufficient Information6
No Information3
Burn(s)1
Death1
Intraoperative Cardiac Valve Injury1

Recent adverse event reports

The 25 most recent of 136 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 8, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671209 ↗
MalfunctionAug 20, 2026Pacing Problem
Patient problems: Insufficient Information
MAUDE report 50354595 ↗
MalfunctionAug 11, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213448 ↗
MalfunctionAug 11, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50207880 ↗
MalfunctionJun 1, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA MULTIFUNCTION CABLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348468 ↗
MalfunctionMay 5, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086140 ↗
MalfunctionApr 1, 2026Use of Device Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DID NOT RESPOND TO THE FRONT PANEL CONTROLS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757145 ↗
MalfunctionMar 13, 2026Unable to Obtain Readings; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST FOR ECG FUNCTION AND DISPLAYED AN "ERROR FFFF" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589417 ↗
MalfunctionFeb 11, 2026Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 76" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316567 ↗
MalfunctionFeb 5, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273404 ↗
MalfunctionDec 26, 2025Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. 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 23898476 ↗
MalfunctionNov 24, 2025Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631204 ↗
MalfunctionNov 6, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 72" AND "DEFIB FAULT 76" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23488377 ↗
MalfunctionNov 5, 2025No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23474896 ↗
MalfunctionOct 9, 2025Unable to Obtain Readings; Defibrillation/Stimulation Problem; Unable to Obtain Readings; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "ERROR FFFF" MESSAGE, AND THE DEVICE DISPLAYED A "DEFIB PAD SHORT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23260715 ↗
MalfunctionAug 13, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB FAULT 72" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22794582 ↗
MalfunctionAug 7, 2025Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "PACER DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738815 ↗
MalfunctionJul 17, 2025Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "DEFIB FAULT 79" AND "PACER FAULT 122" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22532842 ↗
MalfunctionJul 7, 2025Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412547 ↗
MalfunctionJun 5, 2025Failure to Charge; Erratic or Intermittent Display; Failure to Charge; Erratic or Intermittent Display
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S DISPLAY WAS FLICKERING AND THE DEVICE WAS UNABLE TO CHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22149131 ↗
MalfunctionMay 8, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 67-YEAR-OLD MALE PATIENT, THE DEFIBRILLATOR FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN CONTINUED TREATMENT. THE COMPLAINT 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 21987961 ↗
MalfunctionApr 1, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB FAULT 76" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21741669 ↗
MalfunctionFeb 24, 2025No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21450659 ↗
MalfunctionNov 1, 2024Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED 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 20586281 ↗
MalfunctionOct 24, 2024Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20521371 ↗

Device details

UDI-DI	`00847946017279`
Brand	R SERIES
Model	30001001001110012
Company	Zoll Medical Corporation
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2026

Device type (GMDN): Rechargeable professional automated external defibrillator

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. The device is intended to be operated by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries that must be charged when not in use.

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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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