FDA Adverse Event
Malfunction
Summary report: N
AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 19312050
·
Received May 14, 2024
Report
- Report Number
- 3026007685-2024-00001
- Event Type
- Malfunction
- Date Received
- May 14, 2024
- Date of Event
- April 5, 2024
- Report Date
- May 6, 2024
- Manufacturer
- AVIVE SOLUTIONS, INC.
- Product Code
- MKJ
- PMA / PMN Number
- P210015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AVIVE HAS REPORTED ALL INFORMATION AVAILABLE AT THIS TIME. AVIVE HAS REQUESTED RETURN OF THE DEVICE FOR INVESTIGATION. ATTEMPTS TO CONTACT THE CUSTOMER FOR MORE INFORMATION HAVE BEEN UNCUCCESSFUL. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 0
THE CUSTOMER CONTACTED AVIVE TO REPORT THE AED IS UNRESPONSIVE TO ALL BUTTON PRESSES AND ACTIONS WHILE THE DEVICE IS INDICATING IT IS READY FOR USE (DEMONSTRATED BY THE BLINKING GREEN STATUS LIGHT). THE OBSERVATION WAS MADE WHILE INSPECTING THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514461 | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | AVIVE SOLUTIONS, INC. | AED01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |