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	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The end user in charge of managing all aeds for us marshalls service discovered this aed was not powerin gon after charging for 24 hours.There was no response from the aed when the power button was pressed, when prompted to do a status check and when the pad cartridge was removed.Additionally, there were no buttons or lights flashing at any time.
Additional Manufacturer Narrative
Avive has reported all information available at this time.A follow up report will be submitted once the investigation is complete.

• 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 dr; brisbane CA 94005
• Manufacturer Contact: gabrielle logan ; 185 valley dr; brisbane, CA 94005
• MDR Report Key: 20082289
• Report Number: 3026007685-2024-00006
• Device Sequence Number: 7561590
• Product Code: MKJ
• UDI-Device Identifier: 00860002508559
• UDI-Public: 00860002508559
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial 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