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.There were no pads attatched to the aed.The aed powered on and displayed a service code.The service code was cleared after performing a manual self-test however the aed began alerting "pads missing".Although requested, the log files from the device have not been provided and the cause of the complaint is not known.
Additional Manufacturer Narrative
Evaluation of the the log files from this aed could not confirm the reported issue.On 1/01/25 the aed identified that the aed battery was getting low and attempted to alert the user by flashing its red asi and chirping.On 3/10/25 replacement battery serial number 430446981 was installed and subsequently unistalled.Based on the log files the unit was without a battery until 10/08/25 when a replacement battery serial number 430459150 pack and pads were installed into the aed.The review identified that the aed functioned as designed and can 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: 23480960
• Report Number: 3003521780-2025-01763
• Device Sequence Number: 10227900
• 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: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2019
• 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