Lifeline DDU-100ERecalls & reported problems

All models of Lifeline (2)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This DefibTech Lifeline defibrillator has 174 adverse event reports, with no deaths and 1 injury. The reports mostly describe the unit failing to power on, batteries discharging early, and service codes appearing, and many say the problem happened outside patient use. One recall is open, started in March 2025, over labels and instructions that lack an Italian translation. Reports rose to 172 in the latest 12 months from 1 in the prior 12 months.

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: 177
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 00815098020034), received between Sep 29, 2022 and Sep 30, 2026 — classified as 1 injury, 176 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (73 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K013896); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Recalls naming this device

Mar 18, 2025Open, Classified
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Z-1690-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Failure to Power Up73
Premature Discharge of Battery65
Battery Problem18
No Audible Prompt/Feedback10
Failure to Deliver Shock/Stimulation8
Audible Prompt/Feedback Problem2
Insufficient Device Problem Information1

Patient problems

No Clinical Signs, Symptoms or Conditions176
Cardiac Arrest1

Recent adverse event reports

The 25 most recent of 177 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953764 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927997 ↗
MalfunctionSep 29, 2026Failure to Power Up
An international distributor reported that their customer's AED would not power on; however, when tested with a spare battery pack, it did power on and prompted a service code. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927982 ↗
MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927975 ↗
MalfunctionSep 23, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873432 ↗
MalfunctionSep 22, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859373 ↗
MalfunctionSep 22, 2026Premature Discharge of Battery
An international distributor reported their customer's AED battery was depleted. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853440 ↗
MalfunctionSep 22, 2026Failure to Power Up
An international distributor reported their customer's AED would not power on. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853438 ↗
MalfunctionSep 14, 2026Failure to Power Up
A customer reported that their AED's ASI is flashing red, and the AED will not power on. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755247 ↗
MalfunctionSep 14, 2026Premature Discharge of Battery
An international distributor reported their customer's AED is flashing red and prompting a "replace battery pack now warning." The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753888 ↗
MalfunctionSep 14, 2026Failure to Power Up
An international distributor reported that their customer's AED would not power on; however, when tested with a spare battery pack, it powered on. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753881 ↗
MalfunctionSep 11, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741147 ↗
MalfunctionSep 10, 2026No Audible Prompt/Feedback
An international distributor reported a customer's AED will not speak. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714653 ↗
MalfunctionSep 10, 2026Premature Discharge of Battery
An international distributor reported their customer's AED is flashing red and prompting a "replace battery pack now warning". The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714650 ↗
MalfunctionSep 8, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676678 ↗
MalfunctionAug 31, 2026Failure to Power Up
An international distributor reported their customer's AED ASI is flashing red, and the device is reporting a service code. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524498 ↗
MalfunctionAug 31, 2026Failure to Power Up
An international distributor reported that their customer's AED would not power on; however, when tested with a spare battery pack, the AED powered on. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524489 ↗
MalfunctionAug 31, 2026Failure to Power Up
An international distributor reported that their customer's AED would not power on; however, when tested with a spare battery pack, it did power on and prompted a service code. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524483 ↗
MalfunctionAug 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498136 ↗
MalfunctionAug 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498132 ↗
MalfunctionAug 28, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498129 ↗
MalfunctionAug 28, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498123 ↗
MalfunctionAug 26, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463612 ↗
MalfunctionAug 24, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419050 ↗
MalfunctionAug 13, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230434 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013896. One submission often covers many models, so check the product and lot details in each record.

Z-2064-2011 · Apr 1, 2011 · Terminated
Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 or earlier The product under correction is the DDU-100 AED. The AED is indicated for
Z-0077-2011 · Aug 27, 2010 · Terminated
DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does not have its own inte
Z-1781-2010 · May 21, 2010 · Terminated
Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an
Z-1782-2010 · May 21, 2010 · Terminated
ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accesso
Z-0580-2007 · Feb 17, 2007 · Terminated
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)

Device details

UDI-DI	`00815098020034`
Brand	Lifeline
Model	DDU-100E
Company	Defibtech, L.L.C.
Product code	MKJ · Automated External Defibrillators (Non-Wearable)
Class	Class 3
FDA submission	K013896
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Non-rechargeable public semi-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. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback.

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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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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