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

Model Number	DDU-100B
Medical Device Problem Codes	Failure to Power Up (1476); No Audible Prompt/Feedback (2282)
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.When tested with a new battery the aed powered on but did not emit audible prompts.The customer did not report this occurring during patient use.
Additional Manufacturer Narrative
Analysis of the aed's log files identified the cause of the aed not powering on was related to a depleted battery.Once a new battery was installed the aed powered on.Toubleshooting of the device with customer service confirmed the aed did not provide audible prompts upon powering up with the replacement battery.Analysis of the aed's log files did not identify a cause for the depleted battery pack or the reported audio issue.

• 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: 50211048
• Report Number: 3003521780-2026-01298
• Device Sequence Number: 6099477
• Product Code: MKJ
• UDI-Device Identifier: 00815098020027
• UDI-Public: (01)00815098020027
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 07/15/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2021
• 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