Lifeline Auto DDU-120ERecalls & reported problems
Defibtech, L.L.C. · Class 3
All models of Lifeline Auto (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
Defibtech Lifeline Auto defibrillator. Reports mostly describe power-up failures and premature battery discharge, with some no-audible-prompt and shock-delivery issues. There are 97 adverse event reports, no deaths, and 3 injuries. There are no recalls for this device. It had 96 reports in the last 12 months versus 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
- 111
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00815098020072), received between Sep 2, 2025 and Sep 29, 2026 — classified as 3 injuries, 108 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (56 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up56
- Premature Discharge of Battery39
- No Audible Prompt/Feedback6
- Battery Problem5
- Failure to Deliver Shock/Stimulation4
- Device Sensing Problem1
- Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions111
Recent adverse event reports
The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Power Up
An international distributor reported that 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 50927994 ↗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. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927979 ↗MalfunctionSep 25, 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 50892890 ↗MalfunctionSep 22, 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 50853437 ↗MalfunctionSep 17, 2026Premature Discharge of Battery
A customer reported that their AED's ASI is flashing red, and the device is reporting a battery low warning. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805454 ↗MalfunctionSep 17, 2026Premature Discharge of Battery
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 50805452 ↗MalfunctionSep 16, 2026Premature Discharge of Battery
An international distributor reported their customer's AED ASI is flashing red, and the device is reporting a battery low warning. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790252 ↗MalfunctionSep 16, 2026Failure to Power Up
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 50790251 ↗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 50753883 ↗MalfunctionSep 14, 2026Failure to Power Up
An international distributor reported that their customer's AED was reporting a battery low warning. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753858 ↗MalfunctionSep 10, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714652 ↗MalfunctionSep 10, 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 50714651 ↗MalfunctionSep 10, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714649 ↗MalfunctionSep 10, 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 50714648 ↗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 50714647 ↗MalfunctionSep 10, 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 50714646 ↗MalfunctionSep 1, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545161 ↗MalfunctionAug 31, 2026Failure to Power Up
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 50524502 ↗MalfunctionAug 31, 2026Failure to Power Up
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 50524495 ↗MalfunctionAug 31, 2026Failure to Power Up
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 50524492 ↗MalfunctionAug 31, 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 50524484 ↗MalfunctionAug 24, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419053 ↗MalfunctionAug 24, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419049 ↗MalfunctionAug 13, 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 50230430 ↗MalfunctionAug 11, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213804 ↗
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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