Definition: The Device Is An Automatic External Defibrillator Which Monitors And Treats A Patient For Ventricular Defibrillation. Device Is Intended To Be Worn In Home Or In Hospital Settings As Prescribed And Overseen By A Physician.
| Device Type ID | 1040 |
| Device Name | Wearable Automated External Defibrillator |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MVK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1040 |
| Device | Wearable Automated External Defibrillator |
| Product Code | MVK |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 34 |
Monitor | 27 |
Failure To Power Up | 19 |
Inappropriate Shock | 14 |
Device Displays Incorrect Message | 9 |
Device Inoperable | 8 |
Inappropriate Or Unexpected Reset | 7 |
Signal Artifact | 7 |
Reset Problem | 6 |
Battery | 4 |
Battery Problem | 4 |
Device Sensing Problem | 4 |
Communication Or Transmission Problem | 4 |
Electrode | 3 |
Failure Of Device To Self-Test | 3 |
Loss Of Power | 2 |
Use Of Device Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Failure To Fire | 1 |
Charging Problem | 1 |
False Alarm | 1 |
Over-Sensing | 1 |
Patient-Device Incompatibility | 1 |
Battery Charger | 1 |
Connection Problem | 1 |
Wire | 1 |
High Impedance | 1 |
Structural Problem | 1 |
No Audible Alarm | 1 |
No Display / Image | 1 |
Detachment Of Device Component | 1 |
Failure To Convert Rhythm | 1 |
Seal, Defective | 1 |
Belt | 1 |
Component Falling | 1 |
Gel Leak | 1 |
Cut In Material | 1 |
Defective Device | 1 |
Insufficient Information | 1 |
| Total Device Problems | 182 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Zoll Manufacturing Corp. | II | Jan-14-2018 |