Lifeline DDU-100ARecalls & reported problems
Defibtech, L.L.C. · Class 3
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Lifeline DDU-100A defibrillator from Defibtech delivers electric shocks to restore a normal heartbeat. The FDA database holds 545 reports, mostly describing units that fail to power up or lose battery charge early, with 3 deaths and no injuries. One open recall, from February 2023, names this device over an untested sub-assembly part that could stop shock delivery. Reports rose from 2 in the previous 12 months to 543 in the last 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
- 640
- Deaths reported
- 3
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 640 adverse event reports that list this exact device (DI 00815098020003), received between Jun 19, 2025 and Sep 30, 2026 — classified as 3 deaths, 1 injury, 636 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (377 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
Recalls naming this device
- Feb 14, 2023Open, Classified
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
Z-1312-2023 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Failure to Power Up377
- Premature Discharge of Battery209
- Battery Problem25
- Failure to Deliver Shock/Stimulation19
- Inaudible or Unclear Audible Prompt/Feedback6
- No Audible Prompt/Feedback5
- Defibrillation/Stimulation Problem1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- No Clinical Signs, Symptoms or Conditions631
- Insufficient Information9
Recent adverse event reports
The 25 most recent of 640 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953769 ↗MalfunctionSep 30, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953768 ↗MalfunctionSep 30, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953765 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951838 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
A customer reported their AED's ASI 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 50951837 ↗MalfunctionSep 29, 2026Failure to Power Up
A customer reported that their AED's 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 50935602 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935601 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935600 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935599 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935597 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935596 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935595 ↗MalfunctionSep 26, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908149 ↗MalfunctionSep 26, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908148 ↗MalfunctionSep 26, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908146 ↗MalfunctionSep 26, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908144 ↗MalfunctionSep 26, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908142 ↗MalfunctionSep 26, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906479 ↗MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903615 ↗MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903608 ↗MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903605 ↗MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903604 ↗MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903600 ↗MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903599 ↗MalfunctionSep 25, 2026Failure to Power Up
A customer reported their AED's ASI 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 50892896 ↗
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-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-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-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
- Lifeline Configuration DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 death1,285 reports
- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.