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 blank, and the aed will not power on.The customer did not report this occurring during patient use.
Additional Manufacturer Narrative
Troubleshooting of the aed with the customer identified that the aed pads were expired as of 2024/07/31.During the aed's automated self-test, the aed would have identified that the pads were expired and attempted to alert the user by flashing its red asi and chirping.The aed would continue to chirp and flash until the aed's condition is addressed or the battery pack becomes completely depleted.The cause of the aed not powering on was related to a failure to set-up the aed and maintain the battery pack.
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 a new battery was installed and a manual self test performed the aed functioned as designed and was able 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 CT 06405
• Manufacturer Contact: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 23840489
• Report Number: 3003521780-2025-01983
• Device Sequence Number: 13122885
• Product Code: MKJ
• UDI-Device Identifier: 10815098020222
• UDI-Public: (01)10815098020222
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/18/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2018
• 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