MAUDE Adverse Event Report: Defibtech, L.L.C. ReviveR; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number	DDU-100B
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
Troubleshooting of the aed with the customer identified that once a new battery was installed and a manual self test run the aed functioned as designed and could stay in service.Troubleshooting of the aed with the customer did not identify a cause for the depleted battery pack.As a follow up with the customer, the proper maintenance of this device was reviewed.

• 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 ; +1(203)453-6654
• MDR Report Key: 50589264
• Report Number: 3003521780-2026-01509
• Device Sequence Number: 18698381
• Product Code: MKJ
• UDI-Device Identifier: 00815098020027
• UDI-Public: (01)00815098020027
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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-100B
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2022
• 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