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

Model Number	AED01
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The aed device and pad cartridge were not returned to avive for investigation.While this device was not returned, the customer provided a photo of the aed and pads cartridge.This photo shows a sealed pad cartridge with no evidence of the pads being peeled open.Aed log review of the incident indicated that audio was played to instruct the user to peel open the pads.Additionally, the pad cartridge is labeled with large red text to instruct the user to "peel here" with an arrow of the direction to peel.Based on evidence from aed log review and the customer's description of the event and provided device photo, it is most likely that the user did not know how to peel open and access the pads inside the pad cartridge.
Event or Problem Description
Gym member used the aed outside of normal business hours on another gym member and reported that there were no pads when trying to use the aed.Local manager later onsite saw and confirmed the pads were in the aed device and provided photo of the device.

• 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 CA 94005
• Manufacturer Contact: sanaz mirkhani ; 185 valley drive; brisbane, CA 94005
• MDR Report Key: 24444561
• Report Number: 3026007685-2026-00002
• Device Sequence Number: 21423778
• Product Code: MKJ
• UDI-Device Identifier: 00860002508559
• UDI-Public: 00860002508559
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: AED01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown