Lifeline Configuration DDU-100ERecalls & reported problems

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

Quick summary

This Defibtech Lifeline AED is a portable external defibrillator used in sudden cardiac arrest. Many of its 469 reports describe the unit failing to power on or its battery draining early. The reports include no injuries and no deaths, and reports in the last 12 months fell to 64 from 242 before. 1 open recall names this device, started in March 2025, over missing Italian-language labeling and instructions required for Switzerland.

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: 469
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 469 adverse event reports that list this exact device (DI 10815098020031), received between Mar 21, 2023 and Aug 10, 2026 — classified as 469 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (180 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Device problems

Failure to Power Up180
Premature Discharge of Battery150
Failure to Deliver Shock/Stimulation42
Battery Problem39
No Audible Prompt/Feedback28
Inappropriate/Inadequate Shock/Stimulation14
Connection Problem9
Failure to Sense4

Patient problems

No Clinical Signs, Symptoms or Conditions461
Insufficient Information6
Cardiac Arrest2

Recent adverse event reports

The 25 most recent of 469 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 10, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192581 ↗
MalfunctionJan 19, 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 24109567 ↗
MalfunctionJan 19, 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 24109566 ↗
MalfunctionJan 19, 2026Battery Problem
AN INTERNATIONAL DISTRIBUTOR REPORTED A CUSTOMER'S BATTERY PACK WILL NOT STAY LATCHED IN THEIR AED. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24109560 ↗
MalfunctionJan 19, 2026Battery Problem
AN INTERNATIONAL DISTRIBUTOR REPORTED A CUSTOMER'S BATTERY PACK WILL NOT STAY LATCHED IN THEIR AED. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24109558 ↗
MalfunctionJan 13, 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 24052897 ↗
MalfunctionJan 13, 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 24052896 ↗
MalfunctionJan 13, 2026Premature Discharge of Battery
AN INTERNATIONAL DISTRIBUTOR REPORTED THEIR CUSTOMER'S AED WOULD NOT POWER ON, BUT IT POWERED ON WITH A SPARE BATTERY. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052862 ↗
MalfunctionJan 6, 2026Inaudible or Unclear Audible Prompt/Feedback
AN INTERNATIONAL DISTRIBUTOR REPORTED A CUSTOMER'S AED'S AUDIO PROMPTS ARE NOT CLEAR. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23979779 ↗
MalfunctionJan 6, 2026Failure to Power Up
A CUSTOMER REPORTED THAT THEIR 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 23974071 ↗
MalfunctionJan 6, 2026Premature Discharge of Battery
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 23974052 ↗
MalfunctionJan 5, 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 23963862 ↗
MalfunctionJan 5, 2026Failure to Power Up
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS BLANK, 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 23959152 ↗
MalfunctionDec 20, 2025Failure to Power Up; Failure 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 23858854 ↗
MalfunctionDec 18, 2025Failure to Power Up; Failure to Power Up
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS BLANK, 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 23839866 ↗
MalfunctionDec 18, 2025Premature Discharge of Battery; Premature Discharge of Battery
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 23839863 ↗
MalfunctionDec 18, 2025No Audible Prompt/Feedback; No 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 23839855 ↗
MalfunctionDec 17, 2025Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear 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 23835459 ↗
MalfunctionDec 17, 2025Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear 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 23835458 ↗
MalfunctionDec 17, 2025Failure to Power Up; Failure to Power Up
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS FLASHING RED, AND REPORTING A SERVICE CODE. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832255 ↗
MalfunctionDec 17, 2025Premature Discharge of Battery; Premature Discharge of Battery
A CUSTOMER REPORTED THEIR AED IS FLASHING RED AND PROMPTING A "REPLACE BATTERY PACK NOW" WARNING. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829587 ↗
MalfunctionDec 15, 2025Premature Discharge of Battery; Premature 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 23809755 ↗
MalfunctionDec 15, 2025Premature Discharge of Battery; Premature 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 23809750 ↗
MalfunctionDec 15, 2025Premature Discharge of Battery; Premature Discharge of Battery
AN INTERNATIONAL DISTRIBUTOR REPORTED THEIR CUSTOMER'S AED WOULD NOT POWER ON, BUT IT POWERED ON WITH A SPARE BATTERY. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809742 ↗
MalfunctionDec 15, 2025Premature Discharge of Battery; Premature Discharge of Battery
AN INTERNATIONAL DISTRIBUTOR REPORTED THEIR CUSTOMER'S AED WOULD NOT POWER ON, BUT IT POWERED ON WITH A SPARE BATTERY. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809736 ↗

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	`10815098020031`
Brand	Lifeline Configuration
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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.