DDU-1XX series Battery Pack Configuration DBP-1400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815098020369), received between Mar 29, 2024 and Nov 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN INTERNATIONAL DISTRIBUTOR REPORTED AN AED BATTERY THAT APPEARS TO BE SPLIT AT THE BATTERY PLASTICS WELDING POINT. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20739855 ↗
• MalfunctionMar 29, 2024Failure to Power Up; Failure to Power Up

  A CUSTOMER REPORTED THAT THEIR AED BATTERY WAS DEPLETED. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE. THEY DID NOT PROVIDE ANY AED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007715 ↗

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)