AVIVE AED WITH AVIVE CONNECT
Report
- Report Number
- 3026007685-2024-00002
- Event Type
- Death
- Date Received
- May 15, 2024
- Date of Event
- April 15, 2024
- Report Date
- May 14, 2024
- Manufacturer
- AVIVE SOLUTIONS, INC.
- Product Code
- MKJ
- UDI-DI
- 00860002508559
- PMA / PMN Number
- P210015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1547200 | AVIVE AED WITH AVIVE CONNECT | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | AVIVE SOLUTIONS, INC. | 00860002508559 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |