MAUDE Adverse Event Report: AVIVE SOLUTIONS, INC. AVIVE AED WITH AVIVE CONNECT; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number	AED01
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported "when i pulled the aed pads from my avive aed, they never activated and it never recognized that i had applied them.Another care team member arrived just after me so we used another avive aed and it worked and shocked the patient.".

• Brand Name: AVIVE AED WITH AVIVE CONNECT
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): AVIVE SOLUTIONS, INC.; 185 valley drive; brisbane CA 94005
• Manufacturer (Section G): AVIVE SOLUTIONS, INC.; 185 valley drive; brisbane 94005
• Manufacturer Contact: sanaz mirkhani ; 185 valley drive; brisbane 94005
• MDR Report Key: 23864208
• Report Number: 3026007685-2025-00005
• Device Sequence Number: 10006270
• Product Code: MKJ
• UDI-Device Identifier: 00860002508559
• UDI-Public: 00860002508559
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P210015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: AED01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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