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

Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Death
Event or Problem Description
The customer contacted avive to report while using the device on a patient, the device was unable to detect the patient after electrode pads were placed on the patient.The customer provided the following details during a follow up with the customer: the patient was hit by a car and was unresponsive at the scene.Once police arrived, the device was placed on the patient.
Additional Manufacturer Narrative
The customer contacted avive to report that while using the device on a patient, the device was unable to detect the patient after electrode pads were placed on the patient.The device and electrode pads were returned to avive for investigation.The device was put through thorough testing.The device was able to successfully detect a physiological patient simulator at the nominal, lower and upper bound impedances and deliver multiple defibrillation shocks within spec.Additionally, an internal inspection of the device electronics showed no evidence of issues or failed components, further corroborating the ability to successfully detect impedance across the full range.The electrode pads were investigated and showed no evidence of poor electrical connection, mechanical disconnection, or material failures.Investigation of the device logs revealed that the patient impedance was outside of the acceptable impedance range for the entirety of the event.This indicates that the pads were not making proper connection to the patient, which can occur for multiple reasons.The device was scrapped and the customer was shipped a replacement device.
Additional Manufacturer Narrative
The customer contacted avive to report that while using the device on a patient, the device was unable to detect the patient after electrode pads were placed on the patient.The device and electrode pads were returned to avive for investigation.The device was put through thorough testing.The device was able to successfully detect a physiological patient simulator at the nominal, lower and upper bound impedances and deliver multiple defibrillation shocks within spec.Additionally, an internal inspection of the device electronics showed no evidence of issues or failed components, further corroborating the ability to successfully detect impedance across the full range.The electrode pads were investigated and showed no evidence of poor electrical connection, mechanical disconnection, or material failures.Investigation of the device logs revealed that the patient impedance was outside of the acceptable impedance range for the entirety of the event.This indicates that the pads were not making proper connection to the patient, which can occur for multiple reasons.The device was scrapped and the customer was shipped a replacement device.
Event or Problem Description
The customer contacted avive to report while using the device on a patient, the device was unable to detect the patient after electrode pads were placed on the patient.The customer provided the followng details during a follow up with the customer: the patient was hit by a car and was unresponsive at the scene.Once police arrived, the device was placed on the patient.

• 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: 19323410
• Report Number: 3026007685-2024-00002
• Device Sequence Number: 7577463
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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?: Yes
• Operator of Device: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• 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: 05/15/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown