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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer called in saying their aed will not charge.They had it plugged in for about two weeks.The screen does not turn on and the aed does not turn on either.When the customer plugged in the device, the aed flashed red for a second.Upon unplugging and replugging in, the device did not flash.Additionally, the aed was unresponsive when performing a status check.
Additional Manufacturer Narrative
Investigation was conducted and it was observed there was residue on the pcbas and housings.The residue is most likely due to liquid damage as a result of user mishandling.
Event or Problem Description
Customer called in saying their aed will not charge.They had it plugged in for about two weeks.The screen does not turn on and the aed does not turn on either.When the customer plugged in the device, the aed flashed red for a second.Upon unplugging and replugging in, the device did not flash.Additionally, the aed was unresponsive when performing a status check.

• Brand Name: AVIVE AED WITH AVIVE CONNECT
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): AVIVE SOLUTIONS, INC.; 185 valley dr; brisbane CA 94005
• MDR Report Key: 20736880
• Report Number: 3026007685-2024-00012
• Device Sequence Number: 21021678
• Product Code: MKJ
• UDI-Device Identifier: 00860002508559
• UDI-Public: 00860002508559
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown