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

Model Number	DDU-A2300
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
Troubleshooting was performed using a spare battery, and the aed powered on and displayed a service code.The service code was cleared after performing a manual self-test.Although requested, the log files from the device have not been provided and the cause of the complaint is not known.
Event or Problem Description
A customer reported that several aeds at their facility were found to be non-functional.The customer indicated they were not aware of the maintenance history of the affected units.The customer did not report this occurring during patient use.
Additional Manufacturer Narrative
A customer reported that several aeds at their facility were found to be non-functional.The customer indicated they were not aware of the maintenance history of the affected units.Review of the device internal log files showed the aed began reporting a service code on 10/01/2024.The log data indicated that battery pack serial number (b)(6) was ejected on 10/23/2024.Battery pack serial number (b)(6) was subsequently installed on 10/08/2025.The aed was powered on and a manual self-test was performed, which cleared the service code.Review of the available log data did not identify evidence of a device malfunction.

• 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: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 23480965
• Report Number: 3003521780-2025-01760
• Device Sequence Number: 18698945
• Product Code: MKJ
• UDI-Device Identifier: 10815098020208
• UDI-Public: (01)10815098020208
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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-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: 10/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2019
• 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