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

Model Number	AED01
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2026
Type of Reportable Event	Serious Injury

• 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: 50701746
• Report Number: 3026007685-2026-00007
• Device Sequence Number: 14925559
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: AED01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Female