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

Model Number	DDU-100C
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This aed nor its electronic log files were returned and thus the root cause could not be determined.
Event or Problem Description
An international distributor reported their customer's aed would not power on.They reported this did not occur during patient use.
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.The cause of the aed not powering on was related to a failure of the customer to set-up the aed and maintain the battery pack.

• Brand Name: LIFELINE
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS
• 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: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 22350047
• Report Number: 3003521780-2025-00733
• Device Sequence Number: 15583427
• Product Code: MKJ
• UDI-Device Identifier: 10815098020017
• UDI-Public: (01)10815098020017
• 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: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DDU-100C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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