Lifeforce Configuration DDU-100CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815098020017), received between Nov 15, 2024 and Jun 27, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Failure to Power Up; Failure to Power Up

  AN INTERNATIONAL DISTRIBUTOR REPORTED THEIR CUSTOMER'S AED WOULD NOT POWER ON. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350047 ↗
• MalfunctionNov 15, 2024Battery Problem; Battery Problem

  AN INTERNATIONAL DISTRIBUTOR REPORTED THEIR CUSTOMER'S AED IS 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 20699137 ↗

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 · Terminated
  Defibtech 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 · Terminated
  DDC-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-1782-2010 · May 21, 2010 · Terminated
  ReviveR 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-1781-2010 · May 21, 2010 · Terminated
  Lifeline 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-0580-2007 · Feb 17, 2007 · Terminated
  Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)