FDA Adverse Event
Malfunction
Summary report: N
AVIVE AED WITH AVIVE CONNECT
MDR report key: 25130559
·
Received May 8, 2026
Report
- Report Number
- 3026007685-2026-00004
- Event Type
- Malfunction
- Date Received
- May 8, 2026
- Date of Event
- April 11, 2026
- Report Date
- May 8, 2026
- Manufacturer
- AVIVE SOLUTIONS, INC.
- Product Code
- MKJ
- UDI-DI
- 00860002508559
- PMA / PMN Number
- P210015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. AVIVE WILL CONTINUE TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA PER 21 CFR 803.56.
Description of Event or Problem · 0
USER REPORTED THAT THE AED PADS WERE APPLIED TO THE PATIENT, HOWEVER, THE DEVICE NEVER DETECTED THE PATIENT. PER THE USER, THE DEVICE KEPT REQUESTING PADS TO BE PLACED ON PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339000 | AVIVE AED WITH AVIVE CONNECT | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | AVIVE SOLUTIONS, INC. | AED01 | 00860002508559 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Female | Life Threatening |