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

Model Number	DDU-E2300
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
Additional Manufacturer Narrative
The customer initially reported that the aed displayed a service code accompanied by a blank screen.Review of the aed's internal log files confirmed that the device had begun generating a "replace battery now" warning in conjunction with the service code.The log file review indicates that the customer did not address the red asi warnings in a timely manner, which contributed to reduced battery life expectancy.This mdr is being submitted because the aed reached full battery depletion without evidence of user intervention or maintenance following the device's red asi warnings indicating that attention or servicing was required.
Event or Problem Description
An international distributor reported that their customer's aed's asi is flashing red, and reporting a service code.They also reported the aed's screen is blank.The customer did not report this occurring during patient use.

• 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: 23584906
• Report Number: 3003521780-2025-01884
• Device Sequence Number: 9532769
• Product Code: MKJ
• UDI-Device Identifier: 10815098020239
• UDI-Public: (01)10815098020239
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 11/18/2025

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-E2300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2018
• 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