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

Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
From the investigation, the root cause for lack of patient detection with the cmpt-00144 device isdue to an incompletely installed electrode pad cartridge during the emergency.It was identified that the cmpt-00144 device required higher than expected force to install the electrode pad cartridge, likely due to excessive gluing.Electrical testing did not reveal any anomalies in behavior of the device and there were no electrical deficiencies identified in the aed electronics that could impact patient detection.From mechanical testing, it appears that the force required to install the cartridge in this device is greater than previously manufactured devices and resulted in the cartridge not being fully installed in the device at the time of the emergency use.If the cartridge was not fully installed, the device could have initially detected the patient, but a slight movement of the device may have disrupted the electrical connection between the pads and aed resulting in the patient not being detected.This root cause appears to be most likely however, because the pad cartridge used during the incident was never returned for investigation it is unknown if it may have contributed to a patient not being detected.
Event or Problem Description
Below is an email that was forwarded from (b)(6).(b)(6), ofc.(b)(6) reported an issue with his avive aed on a recent call.He placed the pads on the patient's chest and the aed said patient detected, as it is supposed to.However, a couple seconds later, it said, "patient not detected" and kept giving instructions about pad placement.The aed never ended up analyzing the patient or delivering a shock.I reviewed his body cam footage and the only thing i noticed was that the pads seemed slightly closer than usual on the patient's chest.Do you mind running this issue past your contact at avive and see if he has any ideas as to what caused the error? i can send over a screenshot of the body cam footage to show what i mean about pad placement (as long as that would not violate any of our disclosure policies).

• 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 94005
• Manufacturer Contact: gabrielle logan ; 185 valley dr; brisbane, CA 94005
• MDR Report Key: 20081408
• Report Number: 3026007685-2024-00005
• Device Sequence Number: 15387579
• Product Code: MKJ
• UDI-Device Identifier: 00860002508559
• UDI-Public: 00860002508559
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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?: 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: 07/10/2024
• 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): Yes
• 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: Death
• Patient Sex: Unknown