ReviveR Configuration DDU-100BRecalls & reported problems
Defibtech, L.L.C. · Class 3
Quick summary
This Defibtech ReviveR is a portable defibrillator used in cardiac emergencies. Its 185 reports include no deaths and no injuries. Many describe the unit failing to power on, batteries running down early, or red battery warnings, and most report no patient effect. Reports in the last 12 months (20) are down from 95 in the prior 12 months, and 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
- 185
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 10815098020024), received between Nov 10, 2023 and Jan 23, 2026 — classified as 185 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (74 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 Up74
- Premature Discharge of Battery69
- Battery Problem20
- Failure to Deliver Shock/Stimulation11
- Mechanical Problem4
- No Audible Prompt/Feedback4
- Audible Prompt/Feedback Problem1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions184
- Unspecified Heart Problem1
Recent adverse event reports
The 25 most recent of 185 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Premature Discharge of Battery
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS FLASHING RED, AND REPORTING A SERVICE CODE. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162034 ↗MalfunctionJan 22, 2026Premature Discharge of Battery
A CUSTOMER REPORTED THEIR AED IS FLASHING RED AND PROMPTING A "REPLACE BATTERY PACK NOW" WARNING. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24149466 ↗MalfunctionJan 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 24085087 ↗MalfunctionJan 13, 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 24055295 ↗MalfunctionJan 13, 2026Failure to Power Up
A CUSTOMER REPORTED THEIR AED IS FLASHING RED AND PROMPTING A "REPLACE BATTERY PACK NOW" WARNING. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24055192 ↗MalfunctionJan 13, 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 24055191 ↗MalfunctionJan 5, 2026Premature Discharge of Battery
A CUSTOMER REPORTED THEIR AED IS FLASHING RED AND PROMPTING A "REPLACE BATTERY PACK NOW" WARNING. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23959130 ↗MalfunctionDec 17, 2025Failure to Power Up; Failure to Power Up
A CUSTOMER REPORTED THAT THEIR NEW REFURBISHED 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 23832246 ↗MalfunctionDec 15, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS FLASHING RED, AND REPORTING A SERVICE CODE. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802014 ↗MalfunctionDec 10, 2025Failure to Power Up; Failure 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 23773918 ↗MalfunctionDec 5, 2025Failure to Power Up; Failure to Power Up
THE CUSTOMER REPORTED THAT THIER ASI WAS BLANK, AND THE AED WOULD NOT POWER ON. THEY ADDITIONALLY REPORTED THAT THE AED'S ASI HAD BEEN FLASHING RED FOR APPROXIMATELY ONE MONTH. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728540 ↗MalfunctionDec 1, 2025Failure to Power Up; Failure 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 23682735 ↗MalfunctionNov 21, 2025Battery Problem; Battery 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 23618773 ↗MalfunctionNov 15, 2025Failure to Power Up; Failure 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 23564978 ↗MalfunctionNov 15, 2025Failure to Power Up; Failure to Power Up
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS FLASHING RED AND WILL NOT POWER ON. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23564012 ↗MalfunctionNov 12, 2025Premature Discharge of Battery; Premature Discharge of Battery
A CUSTOMER REPORTED THAT THEIR AED BATTERY WAS DEPLETED. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536858 ↗MalfunctionNov 7, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS FLASHING RED, AND THE AED 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 23498395 ↗MalfunctionNov 7, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS FLASHING RED, AND THE AED 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 23498386 ↗MalfunctionNov 7, 2025Failure to Power Up; Failure 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 23497703 ↗MalfunctionNov 6, 2025Premature Discharge of Battery; Premature Discharge of Battery
A CUSTOMER REPORTED THEIR AED IS FLASHING RED AND PROMPTING A "REPLACE BATTERY PACK NOW" WARNING. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487776 ↗MalfunctionOct 30, 2025Premature Discharge of Battery; Premature Discharge of Battery
A CUSTOMER REPORTED THAT THEIR AED'S BATTERY WAS DEPLETED. WHEN TESTED WITH A SPARE BATTERY PACK, IT 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 23427151 ↗MalfunctionOct 27, 2025Failure to Power Up; Failure 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 23393087 ↗MalfunctionOct 20, 2025Battery Problem; Battery Problem
A CUSTOMER REPORTED THEIR BATTERY PACK WILL NOT STAY LATCHED IN THEIR AED. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337097 ↗MalfunctionOct 19, 2025Premature Discharge of Battery; Premature Discharge of Battery
A CUSTOMER REPORTED THEIR AED IS FLASHING RED AND PROMPTING A "REPLACE BATTERY PACK NOW" WARNING. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333689 ↗MalfunctionOct 19, 2025Premature Discharge of Battery; Premature Discharge of Battery
A CUSTOMER REPORTED THEIR AED IS FLASHING RED AND PROMPTING A "REPLACE BATTERY PACK NOW" WARNING. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333687 ↗
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.