ReviveR DDU-100BRecalls & reported problems
Defibtech, L.L.C. · Class 3
Quick summary
This Defibtech ReviveR DDU-100B is a non-wearable automated external defibrillator. The 66 reports mostly describe units that would not power on, often with batteries running down early, and sometimes missing voice prompts, with no deaths and no injuries mentioned. No recalls name this device. All 66 reports arrived in the last 12 months, compared with 0 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
- 71
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00815098020027), received between Jan 9, 2026 and Sep 30, 2026 — classified as 71 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (40 reports).
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
Most reported problems
Device problems
- Failure to Power Up40
- Premature Discharge of Battery25
- Battery Problem5
- No Audible Prompt/Feedback2
- Failure to Deliver Shock/Stimulation1
Patient problems
- No Clinical Signs, Symptoms or Conditions71
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951835 ↗MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935604 ↗MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935593 ↗MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903597 ↗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 50855975 ↗MalfunctionSep 22, 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 50855974 ↗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 50855971 ↗MalfunctionSep 14, 2026Failure to Power Up
A customer reported that their AED's ASI is flashing red, 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 50753854 ↗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 50671274 ↗MalfunctionSep 3, 2026Failure to Power Up
A customer reported that their AED's ASI is flashing red, 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 50589264 ↗MalfunctionSep 3, 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 50589263 ↗MalfunctionSep 3, 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 50589257 ↗MalfunctionAug 31, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530885 ↗MalfunctionAug 27, 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 50473903 ↗MalfunctionAug 26, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452382 ↗MalfunctionAug 13, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235405 ↗MalfunctionAug 13, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230431 ↗MalfunctionAug 11, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211050 ↗MalfunctionAug 11, 2026Failure to Power Up; No Audible Prompt/Feedback
A customer reported that their AED's ASI is flashing red, and the AED will not power on. When tested with a new battery the AED powered on but did not emit audible prompts. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211048 ↗MalfunctionAug 8, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50186650 ↗MalfunctionAug 8, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50186647 ↗MalfunctionAug 8, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50186638 ↗MalfunctionAug 6, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164152 ↗MalfunctionAug 6, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164148 ↗MalfunctionAug 6, 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 50160570 ↗
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.