DDU-1XX Series Adult Rescue Pads DDP-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815098020423), received between Jun 8, 2016 and Jun 8, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 14, 2024Class IIOpen, Classified

   Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.

   Z-0502-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2016Device Operates Differently Than Expected

  ON MAY 9, 2016 IT WAS REPORTED BY A PROFESSIONAL USER (EMT) THAT WHEN HE WENT TO USE A SET OF ADULT DEFIBRILLATION PADS ON A PATIENT, HE NOTICED THAT BOTH PADS HAD THE SAME RIGHT APICAL IMAGE. HE STATED THAT HE UNDERSTOOD THE CORRECT LOCATION TO PLACE THE PADS AND THAT HE COULD HAVE USED THEM, BUT CHOSE TO USE A SPARE SET. HE PROVIDED THE ELECTRONIC DATA FROM THE AED USED DURING THE EVENT AND THE ANALYSIS OF THE ELECTRONIC DATA SHOWS THE PATIENT WAS IN AN ASYSTOLIC RHYTHM (A NON-SHOCKABLE RHYTHM) AND THAT THE AED PERFORMED AS INTENDED; NO AED MALFUNCTIONS WERE NOTED. IT WAS REPORTED THAT THE PATIENT WAS NOT RESUSCITATED. NO ADVERSE EVENT CODE WAS SELECTED SINCE THE PATIENT'S ECG WAS NON-SHOCKABLE AND THEREFORE THERE IS NO SUSPECTED ASSOCIATION BETWEEN THE PATIENT'S DEATH AND THE USE OF THE PRODUCT.

  Patient problems: Death

  MAUDE report 5707077 ↗

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)