Lifeline ECG DDU-A2450Recalls & reported problems
Defibtech, L.L.C. · Class 3
All models of Lifeline ECG (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815098020287), received between May 7, 2026 and Sep 8, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deliver Shock/Stimulation1
- Failure to Power Up1
- Premature Discharge of Battery1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 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 50672556 ↗MalfunctionJun 20, 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 25571633 ↗MalfunctionMay 7, 2026Failure to Deliver Shock/Stimulation
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 25112101 ↗
Other Automated External Defibrillators (Non-Wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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