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

Catalog Number	AED01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer attempted to use avive aed device in an emergency but were having trouble with the pad cartridge.User reported that the pad cartridge was recognized by the aed and walked them up to the "place pads on patient" step but the pads would not take a reading on the patient as they did not shave the patient and the pads were not coming in contact with skin.Ems arrived on scene before a reading could be taken and took over from there.Status of the patient is unknown at this time.
Additional Manufacturer Narrative
The device and pad cartridge were not returned to avive for investigation.Investigation of the aed logs revealed that the device was successfully powered on, and audio instructed the user to peel and place the pads on the patient.Logs indicated that the device then started to take impedance readings, which fell between 445-493 ohms.An impedance value in the acceptable threshold falls between 25 and 200 ohms.The impedance values measured by the device fell above the acceptable threshold range for ecg analysis and shock delivery, and the device correctly identified this and played audio to instruct the user to check the pads.This can be due to several factors such as improper pad placement / adherence, debris on the pads, clothing interference, or body surface conditions such as wet skin or body hair.Based on the user's description of the event, it is likely that patient body hair interfered with the proper adherence of the electrode pads.Before the event, the device passed all daily, weekly, and monthly self-tests.There was no deficiency, malfunction, or error identified with the aed device.The event is reported as serious injury because life-saving therapy/treatement may have been intrrupted/delayed.The event date is corrected to (b)(6) 2025 based on the information form the customer.
Event or Problem Description
Customer attempted to use avive aed device in an emergency but were having trouble with the pad cartridge.User reported that the pad cartridge was recognized by the aed and walked them up to the "place pads on patient" step but the pads would not take a reading on the patient as they did not shave the patient and the pads were not coming in contact with skin.Ems arrived on scene before a reading could be taken and took over from there.Status of the patient is unknown at this time.

• 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: 23658970
• Report Number: 3026007685-2025-00004
• Device Sequence Number: 15983569
• Product Code: MKJ
• UDI-Device Identifier: 00860002508559
• UDI-Public: 00860002508559
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 01/16/2026

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 Catalogue Number: AED01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/16/2026
• 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