MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	DDU-E2200
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the log files from the aed showed that the aed was placed into service without the pads connected to the aed.The ddu series aeds are designed to be stored with the pads connector already installed.This simplifies the procedure for deploying and operating the device in an emergency.During the aed's automated self-test, the aed identified that the pads were not connected and attempted to alert the user by flashing its red asi and chirping.The aed continued to chirp and flash without any evidence in the log of any human interaction to address the aeds condition until the battery pack became completely depleted.Analysis of the log files show the aed's battery had completely depleted on (b)(6) 2025.There was no evidence in the electronic logs of any human interaction to address the aeds condition until on (b)(6) 2025 when a replacement battery pack was inserted into the aed.No patient outcome or updates were provided.
Event or Problem Description
An international distributor reported that a customer's aed failed to power on during a rescue attempt.According to the rescuer, no resuscitation was required at the time of the event; however, the emergency line operator advised the rescuer to power on the aed and apply the electrode pads to assess the patient's cardiac rhythm.When attempting to do so, the rescuer discovered that the aed would not turn on.Because the device could not be powered on, the electrode pads were not attached, and the aed was not used.Emergency medical personnel arrived shortly thereafter and assumed care of the patient.No patient harm was reported.The aed has been requested for return and evaluation.

• Brand Name: LIFELINE
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• Manufacturer (Section G): DEFIBTECH, L.L.C.; 14 commercial st.; branford CT 06405
• Manufacturer Contact: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 23622152
• Report Number: 3003521780-2025-01863
• Device Sequence Number: 21100486
• Product Code: MKJ
• UDI-Device Identifier: 10815098020192
• UDI-Public: (01)10815098020192
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DDU-E2200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown