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

Model Number	DDU-E2400
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following analysis of the device logs, the unit was requested for return and further evaluation.Upon receipt, the device underwent bench testing, during which a manual self-test and shock test could not be completed.Further evaluation identified an intermittent connection issue associated with the aed's graphics display module circuit board as the cause of the observed behavior.Although the original customer report was not considered reportable based on the information initially available, evaluation of the returned device confirmed a malfunction that could delay or prevent therapy delivery if it were to occur during a clinical use scenario.Therefore, this event is being reported in accordance with 21 cfr 803.50.
Event or Problem Description
An international distributor reported that their customer's aed asi is flashing red, and the device is reporting a service code.The customer did not report this occurring during patient use.

• 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 ; 2034536654
• MDR Report Key: 25631126
• Report Number: 3003521780-2026-00994
• Device Sequence Number: 9736135
• Product Code: MKJ
• UDI-Device Identifier: 00815098020270
• UDI-Public: (01)00815098020270
• 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): 06/24/2026

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-E2400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2016
• 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