MAUDE Adverse Event Report: Defibtech, L.L.C. Lifeline; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number	DDU-A2300
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that their aed's asi is flashing red, and the device is reporting a service code.The customer did not report this occurring during patient use.
Additional Manufacturer Narrative
Although the customer initially reported a service code, review of the aed's internal log files determined that the service code after battery replacement was due to the previous battery fully depleting within the unit.During the aed's automated self-test on 9/01/23, the aed identified that the pads required replacement 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 on 7/31/24.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.Once a new battery was installed and a manual self test run the aed functioned as designed and could stay in service.

• 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
• Manufacturer Contact: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; +1(203)453-6654
• MDR Report Key: 50935598
• Report Number: 3003521780-2026-01745
• Device Sequence Number: 13445447
• Product Code: MKJ
• UDI-Device Identifier: 00815098020201
• UDI-Public: (01)00815098020201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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-A2300
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2016
• 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