Lifeline Auto DDU-120ARecalls & 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
This Defibtech Lifeline Auto AED is a semi-automatic defibrillator used in emergencies. Its 93 reports, from 2019 to 2026, mostly describe the unit failing to power up and its battery running down early, and one describes pads that would not stick to a wet chest during a water rescue. The reports include 1 death and 1 injury. Reports rose to 90 in the last 12 months from 2 in the 12 months before. 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
- 107
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00815098020041), received between Dec 3, 2019 and Sep 30, 2026 — classified as 1 death, 1 injury, 105 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (54 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 Up54
- Premature Discharge of Battery43
- Battery Problem4
- Failure to Deliver Shock/Stimulation3
- Inappropriate/Inadequate Shock/Stimulation1
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions104
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 107 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 50953767 ↗MalfunctionSep 30, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951836 ↗MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935603 ↗MalfunctionSep 29, 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 50935594 ↗MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903602 ↗MalfunctionSep 22, 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 50855972 ↗MalfunctionSep 15, 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 50772002 ↗MalfunctionSep 14, 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 50753861 ↗MalfunctionSep 10, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720955 ↗MalfunctionSep 8, 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 50672560 ↗MalfunctionSep 3, 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 50589268 ↗MalfunctionSep 3, 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 50589260 ↗MalfunctionSep 2, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573370 ↗MalfunctionSep 2, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564534 ↗MalfunctionSep 2, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564532 ↗MalfunctionSep 2, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564528 ↗MalfunctionAug 27, 2026Premature Discharge of Battery
A customer reported that their AED's battery was depleted. When tested with a spare battery pack, the 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 50473906 ↗InjuryAug 25, 2026Loss of or Failure to Bond
During a rescue attempt involving a patient who had been removed from the water, the customer attempted to use the AED but experienced difficulty getting the defibrillation pads to adhere to the patient's wet, hairy chest. The fire department subsequently arrived, assumed responsibility for the rescue, and used its own equipment. The customer stated that the AED did not malfunction and clarified that the purpose of the inquiry was to replace the pads used during the rescue and potentially purchase additional spare sets. No information regarding the patient's condition or outcome was provided.
Patient problems: Insufficient Information
MAUDE report 50438828 ↗MalfunctionAug 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50436180 ↗MalfunctionAug 13, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235418 ↗MalfunctionAug 13, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230433 ↗MalfunctionAug 13, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230432 ↗MalfunctionAug 13, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230426 ↗MalfunctionAug 11, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211053 ↗MalfunctionAug 11, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50203287 ↗
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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