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

Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
User adam penn discovered the alleged malfunction when he was demonstrating during a training session on (b)(6).When he pressed the white aed power button as well as pulled red tab - there was no reaction from the the aed.He charged the aed overnight - and was still experiencing the same non response from the aed.Over the phone - i had adam plug the aed in and prompt a status check - there was no reaction from the aed.The light was not displaying flashing or color of any kind.
Event or Problem Description
The user discovered the alleged malfunction when he was demonstrating during a training session on 6/21.There was no reaction from the aed when he pressed the white aed power button as well as pulled red tab - there was no reaction from the the aed.He charged the aed overnight - and was still experiencing the same non response from the aed.Over the phone - i had adam plug the aed in and prompt a status check - there was no reaction from the aed.The light was not displaying flashing or color of any kind.
Additional Manufacturer Narrative
During device set-up, the user noticed the aed power button did not react when prompting a status check.The device remained unresponsive after troubleshooting with the device unplugged and no indicator light was present on the device.Logs show the aed had sufficient battery on aed was showing adequate battery power in real connect.When plugged into power: the buttons on top of aed were responsive to presses and the indicator light was blinking red.Additionally, the device audio was scratchy when power button was pressed.

• 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
• Manufacturer (Section G): AVIVE SOLUTIONS, INC.; 185 valley drive; brisbane CA 94005
• Manufacturer Contact: gabrielle logan ; 185 valley drive; brisbane, CA 94005
• MDR Report Key: 19610820
• Report Number: 3026007685-2024-00004
• Device Sequence Number: 18264230
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (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