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
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
Troubleshooting was performed using a spare battery and an expired set of pads, the aed powered on and displayed a service code.The service code was cleared after performing a manual self-test; however, the device then indicated that the pads were expired.Troubleshooting confirmed the pads were expired as of 10/31/2024.Although requested, the log files from the device have not been provided and the cause of the complaint is not known.
Additional Manufacturer Narrative
Analysis of the aed's log files identified that the customer's failure to promptly address red asi warnings reduced battery life expectancy.The cause of the aed not powering on was related to the customers failure to maintain the battery pack.As a follow up with the customer, the proper maintenance of this device was reviewed.Once the new battery was installed and a manual self test performed the aed functioned as designed and was able 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 CT 06405
• Manufacturer Contact: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 23480964
• Report Number: 3003521780-2025-01761
• Device Sequence Number: 18698944
• 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: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2018
• 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