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

Model Number	DDU-C2300
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 their aed's asi is flashing red, and the aed will not power on.The customer did not report this occurring during patient use.
Additional Manufacturer Narrative
Analysis of the log files from the aed showed that the aed was placed into service without the pads connected to the aed.The ddu series aeds are designed to be stored with the pads connector already installed.This simplifies the procedure for deploying and operating the device in an emergency.During the aed's automated self-test, the aed identified that the pads were not connected and attempted to alert the user by flashing its red asi and chirping.The aed continued to chirp and flash without any evidence in the log of any human interaction to address the aeds condition until the battery pack became completely depleted.The cause of the aed not powering on was related to a failure of the customer to set-up the aed and maintain the battery pack.On (b)(6) 2025 the aed identified that the aed identified pads were not attatched and attempted to alert the user by flashing its red asi and chirping.The aed continued to flash and chirp until (b)(6) 2026 when the battery pack was measured at a low state and the aed began reporting low battery.The aed continued to flash and chirp until (b)(6) 2026 when the battery pack became completely depleted.There was no evidence in the electronic logs of any human interaction to address the aeds condition until (b)(6) 2026 when a replacement battery pack was inserted into the aed.The review identified that the aed functioned as designed and can stay in service.

• Brand Name: REVIVER
• 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: 25647125
• Report Number: 3003521780-2026-00999
• Device Sequence Number: 9838898
• Product Code: MKJ
• UDI-Device Identifier: 00815098020225
• UDI-Public: (01)00815098020225
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2026

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-C2300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2018
• 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