Lifeline ECG Configuration DDU-E2450Recalls & 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.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815098020314), received between Aug 17, 2024 and Oct 16, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
- Mar 18, 2025Open, Classified
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Z-1693-2025 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Failure to Power Up2
- Battery Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER REPORTED THAT THE AED WILL NOT POWER ON AND IT WOULD NOT POWER ON EVEN WITH THE TEST BATTERY. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20464907 ↗MalfunctionAug 17, 2024Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem
THE DISTRIBUTOR REPORTED FOR THEIR CUSTOMER THAT THE AED IS DEPLETING BATTERIES PREMATURELY. THIS IS THE SECOND BATTERY PACK TO BE DEPLETED BEFORE ITS EXPIRATION DATE. THE CUSTOMER DID NOT REPORT THIS EVENT OCCURRED DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19998801 ↗
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- 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.