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

Model Number	DDU-100B
Medical Device Problem Code	Premature Discharge of Battery (1057)
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 battery was depleted.The customer did not report this occurring during patient use.
Additional Manufacturer Narrative
Although requested, the log files from the device have not been provided and the cause of the complaint is not known.
Additional Manufacturer Narrative
Analysis of the log files from the aed identified that the customer was performing excessive self-testing of the aed which reduced the battery life expectancy.The customer reported that upon inserting a new battery pack, their aed powered on and prompted a service code.Upon receipt, the device underwent bench testing, during which it was determined that the aed was unable to successfully intiate a shock.Evaluation confirmed that a transistor had sustained damage attributed to the device experiencing a drop or significant impact.

• Brand Name: REVIVER
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• 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: 23536858
• Report Number: 3003521780-2025-01796
• Device Sequence Number: 10202666
• Product Code: MKJ
• UDI-Device Identifier: 10815098020024
• UDI-Public: (01)10815098020024
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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-100B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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