E SERIES 80001730020124013Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO RAILS, DMST, REFURB · Class 3

All models of E SERIES (160)

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

Quick summary

This Zoll E Series defibrillator is a portable automated external defibrillator used for cardiac monitoring and resuscitation. The 33 reports mostly describe units that would not power up or showed blank, white, or streaked screens during shift checks and self-tests, with no patient involved. There are no deaths and no 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: 33
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00847946015640), received between Aug 6, 2015 and Apr 8, 2020 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (19 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.

Most reported problems

Device problems

Failure to Power Up19
Device Displays Incorrect Message5
Failure of Device to Self-Test4
No Display/Image4
Defibrillation/Stimulation Problem1
Device Operational Issue1
Device Stops Intermittently1
Failure to Analyze Signal1

Patient problems

No Patient Involvement31
No Consequences Or Impact To Patient1
No Information1

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 8, 2020No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9938963 ↗
MalfunctionDec 30, 2019Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9532523 ↗
MalfunctionDec 9, 2019Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2019-03737 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9439003 ↗
MalfunctionSep 18, 2019No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S DISPLAY SHOWED VERTICAL LINES AND WAS NOT LEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9083752 ↗
MalfunctionJul 23, 2019Failure 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 Patient Involvement
MAUDE report 8818280 ↗
MalfunctionJul 3, 2019No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8757911 ↗
MalfunctionJun 17, 2019Failure 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 Patient Involvement
MAUDE report 8705157 ↗
MalfunctionApr 12, 2019Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8510868 ↗
MalfunctionDec 14, 2018Failure 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 Patient Involvement
MAUDE report 8164552 ↗
MalfunctionDec 6, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8137891 ↗
MalfunctionOct 23, 2018Failure 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 Patient Involvement
MAUDE report 7995908 ↗
MalfunctionOct 22, 2018Failure 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 Patient Involvement
MAUDE report 7992141 ↗
MalfunctionSep 5, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7846157 ↗
MalfunctionAug 15, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB FAULT 196" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7784799 ↗
MalfunctionJul 19, 2018Failure 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 Patient Involvement
MAUDE report 7702771 ↗
MalfunctionMay 9, 2018Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 78" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7500330 ↗
MalfunctionApr 9, 2018Failure 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 Patient Involvement
MAUDE report 7406234 ↗
MalfunctionMar 7, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7322080 ↗
MalfunctionFeb 20, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7284141 ↗
MalfunctionFeb 7, 2018Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7248340 ↗
MalfunctionJan 30, 2018Failure to Power Up; Device Displays Incorrect Message; Failure to Power Up; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO POWER ON FULLY. NO FURTHER INFORMATION WAS AVAILABLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORTS 1220908-2018-00180, 1220908-2018-00185, 1220908-2018-00187, 1220908-2018-00188, 1220908-2018-00109 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 7228379 ↗
MalfunctionJan 30, 2018Failure to Power Up; Device Displays Incorrect Message; Failure to Power Up; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO POWER ON FULLY. NO FURTHER INFORMATION WAS AVAILABLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORTS 1220908-2018-00180, 1220908-2018-00185, 1220908-2018-00187, 1220908-2018-00188, 1220908-2018-00138 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 7228375 ↗
MalfunctionNov 15, 2017No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S SCREEN TURNED COMPLETELY GRAY AND WAS ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7032747 ↗
MalfunctionOct 18, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "PADDLE FAULT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6957870 ↗
MalfunctionOct 17, 2017Failure 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 Patient Involvement
MAUDE report 6955871 ↗

Device details

UDI-DI	`00847946015640`
Brand	E SERIES
Model	80001730020124013
Company	Zoll Medical Corporation
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Feb 13, 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.

Other Automated external defibrillators (non-wearable) devices

NA 861290
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
12 deaths5,167 reports
NA 861288
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
21 deaths5,015 reports
NA 861289
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
7 deaths3,385 reports
R SERIES 30001005201310012
Zoll Medical Corporation · Automated external defibrillators (non-wearable)
10 deaths1,720 reports
PHILIPS HeartStart FRx
Philips Electronics North America Corporation · Automated external defibrillators (non-wearable)
26 deaths1,586 reports
LIFEPAK CR2 99512
Physio-Control, Inc. · Automated external defibrillators (non-wearable)
8 deaths1,502 reports
Lifeline Configuration DDU-100A
Defibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)
1 death1,285 reports
PHILIPS HeartStart FR3
Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)
10 deaths1,188 reports

All Automated external defibrillators (non-wearable) devices →

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.

How reports and recalls are matched · Editorial policy · Report an error on this page