Lifeline Configuration DDU-100ARecalls & reported problems
Defibtech, L.L.C. · Class 3
Quick summary
This DEFIBTECH Lifeline automated external defibrillator is used during cardiac arrest. Many reports describe the device failing to power on or its battery draining early, and some describe a flashing red status light. The FDA database lists 1,285 reports, with no injuries and 1 death, and reports fell sharply in the last 12 months, to 150 from 641. 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
- 1,285
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,285 adverse event reports that list this exact device (DI 10815098020000), received between Mar 13, 2020 and Jan 23, 2026 — classified as 1 death, 1,284 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (616 reports).
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
Most reported problems
Device problems
- Failure to Power Up616
- Premature Discharge of Battery435
- Battery Problem128
- Failure to Deliver Shock/Stimulation74
- No Audible Prompt/Feedback23
- Mechanical Problem12
- Electrical /Electronic Property Problem6
- Connection Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions1,268
- Insufficient Information11
- Cardiac Arrest3
- Unspecified Heart Problem2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Death1
Recent adverse event reports
The 25 most recent of 1,285 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 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 24164958 ↗MalfunctionJan 23, 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 24164956 ↗MalfunctionJan 23, 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 24164925 ↗MalfunctionJan 23, 2026Battery Problem
A CUSTOMER REPORTED THAT THEIR AED'S BATTERY WAS DEPLETED. WHEN TESTED WITH A SPARE BATTERY PACK, IT POWERED 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 24164911 ↗MalfunctionJan 23, 2026Failure to Deliver Shock/Stimulation
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 24162033 ↗MalfunctionJan 23, 2026Inappropriate/Inadequate Shock/Stimulation
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 24162032 ↗MalfunctionJan 23, 2026Failure to Deliver Shock/Stimulation
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 24162031 ↗MalfunctionJan 23, 2026Premature Discharge of Battery
A CUSTOMER REPORTED THAT THEIR AED'S BATTERY WAS DEPLETED. WHEN TESTED WITH A SPARE BATTERY PACK, IT POWERED 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 24159836 ↗MalfunctionJan 23, 2026Premature Discharge of Battery
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 24159833 ↗MalfunctionJan 23, 2026Premature Discharge of Battery
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 24159819 ↗MalfunctionJan 23, 2026Premature Discharge of Battery
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 24159814 ↗MalfunctionJan 22, 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 24152113 ↗MalfunctionJan 22, 2026Premature Discharge of Battery
A CUSTOMER REPORTED THAT UPON INSERTING A NEW BATTERY PACK, THEIR AED POWERED 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 24151978 ↗MalfunctionJan 22, 2026Premature 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 24149395 ↗MalfunctionJan 21, 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 24136456 ↗MalfunctionJan 21, 2026Premature 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 24136455 ↗MalfunctionJan 21, 2026Battery Problem
A CUSTOMER REPORTED THEIR 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 24136454 ↗MalfunctionJan 19, 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 24109559 ↗MalfunctionJan 15, 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 24085112 ↗MalfunctionJan 15, 2026Premature 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 24085106 ↗MalfunctionJan 13, 2026Premature 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 24055226 ↗MalfunctionJan 13, 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 24055224 ↗MalfunctionJan 13, 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 24055190 ↗MalfunctionJan 13, 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 24055188 ↗MalfunctionJan 13, 2026Battery Problem
A CUSTOMER REPORTED THEIR 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 24052893 ↗
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 · TerminatedDefibtech 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 · TerminatedDDC-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-1782-2010 · May 21, 2010 · TerminatedReviveR 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-1781-2010 · May 21, 2010 · TerminatedLifeline 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-0580-2007 · Feb 17, 2007 · TerminatedDefibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)
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
- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
- AED PLUS 20000000100011010Zoll Medical Corporation · Automated external defibrillators (non-wearable)16 deaths1,072 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.