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

Model Number	DDU-C2300
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although no event date was provided, log file review identified an event on 10/10/2025.The aed powered on with expired pads, prompting a replace pads warning during a user-aborted power-on self-test.The aed was then powered on for an event lasting 374 seconds, during which no shocks were delivered.Pads were disconnected, and the aed was powered off by the user and the aed reported a no pads warning - due to pads not being connected.On (b)(6) 2025, the user initiated a manual self-test and triggered service code 5251 by not pressing the shock button when prompted.This sc is consistent with user error, not device malfunction.
Event or Problem Description
Customer reported the aed did not operate properly during a rescue.Limited event details were available at the time of the call, and the aed was not in their possession.Customer also reported a service code 5251, but it was unclear whether the sc occurred before, during, or after the event.Customer confirmed no death associated with the incident.

• Brand Name: REVIVER
• 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: 23564016
• Report Number: 3003521780-2025-01942
• Device Sequence Number: 9829754
• Product Code: MKJ
• UDI-Device Identifier: 10815098020222
• UDI-Public: (01)10815098020222
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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-C2300
• 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: 11/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2016
• 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