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
Additional Manufacturer Narrative
Although requested, the log files from the device have not been provided and the cause of the complaint is not known.
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 aed's log files identified that the customer's failure to promptly address red asi warnings reduced battery life expectancy.On (b)(6) 2025 the aed identified that the aed battery was getting low and attempted to alert the user by flashing its red asi and chirping.The aed continued to flash and chirp until (b)(6) 2025 when the battery pack was measured at a critically low state and the aed began reporting replace battery pack now.The aed continued to flash and chirp until (b)(6) 2025 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) 2025 when a replacement battery pack was inserted into the aed.
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.On (b)(6) 2025 the aed identified that the aed battery was getting low and attempted to alert the user by flashing its red asi and chirping.The aed continued to flash and chirp until (b)(6) 2025 when the battery pack was measured at a critically low state and the aed began reporting replace battery pack now.The aed continued to flash and chirp until (b)(6) 2025 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) 2025 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 CT 06405
• Manufacturer Contact: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 24055191
• Report Number: 3003521780-2025-02189
• Device Sequence Number: 9495058
• Product Code: MKJ
• UDI-Device Identifier: 10815098020024
• UDI-Public: (01)10815098020024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 01/13/2026

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: 12/19/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2016
• 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