Definition: P030011
| Device Type ID | 1007 |
| Device Name | Artificial Heart |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LOZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1007 |
| Device | Artificial Heart |
| Product Code | LOZ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Driver | 597 |
Alarm, Audible | 291 |
Adverse Event Without Identified Device Or Use Problem | 226 |
Battery | 124 |
Device Displays Incorrect Message | 120 |
Audible Prompt / Feedback | 100 |
Battery Problem | 98 |
Device Operates Differently Than Expected | 91 |
Appropriate Term/Code Not Available | 90 |
Noise, Audible | 86 |
Mechanical Problem | 79 |
Device Component Or Accessory | 77 |
Power Supply | 72 |
Electrical /Electronic Property Problem | 57 |
Alarm | 47 |
Power Problem | 44 |
Device Operational Issue | 39 |
Physical Property Issue | 35 |
Charging Problem | 31 |
Connection Problem | 28 |
No Apparent Adverse Event | 25 |
Display Or Visual Feedback Problem | 23 |
Connector | 22 |
Display | 19 |
Regulator | 17 |
Failure To Charge | 16 |
Cannula | 16 |
No Display / Image | 15 |
Adapter (Adaptor) | 14 |
Break | 13 |
Spring | 13 |
Output Problem | 10 |
Loose Or Intermittent Connection | 9 |
Difficult To Insert | 8 |
Material Integrity Problem | 8 |
PC (Printed Circuit) Board | 8 |
Low Readings | 7 |
Housing | 7 |
Device Alarm System | 7 |
Filling Problem | 7 |
Compressor (Air Pump) | 7 |
Device Issue | 6 |
Computer Operating System Problem | 6 |
Material Rupture | 6 |
Lock | 6 |
Use Of Device Problem | 6 |
False Alarm | 5 |
Valve | 5 |
Insufficient Information | 5 |
Charger | 5 |
Human Factors Issue | 4 |
Pressure Problem | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 4 |
Calibration Problem | 4 |
Crack | 4 |
Erratic Or Intermittent Display | 4 |
Difficult To Remove | 4 |
Material Puncture / Hole | 4 |
High Readings | 4 |
Latch | 3 |
Premature Discharge Of Battery | 3 |
Improper Device Output | 3 |
Device Inoperable | 3 |
Low Battery | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Computer Hardware | 3 |
Device Subassembly | 3 |
Plug | 3 |
Device Handling Problem | 3 |
Material Too Rigid Or Stiff | 3 |
Air Leak | 3 |
Failure To Power Up | 2 |
Material Separation | 2 |
Device Damaged By Another Device | 2 |
Image Display Error / Artifact | 2 |
Socket | 2 |
Nonstandard Device | 2 |
Temperature Problem | 2 |
Failure To Disconnect | 2 |
Component Falling | 2 |
Computer Software Problem | 2 |
Disconnection | 2 |
Display Difficult To Read | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Diaphragm | 2 |
Failure To Sense | 2 |
Fan | 2 |
Screw | 2 |
Other (code Unspecified, Describe In H.10) | 1 |
Failure To Pump | 1 |
Component Missing | 1 |
Overfill | 1 |
Tip | 1 |
Failure To Eject | 1 |
Wire | 1 |
Potentiometer | 1 |
Mount | 1 |
Screen | 1 |
Screw Head | 1 |
Component Misassembled | 1 |
| Total Device Problems | 2771 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | SynCardia Systems Inc. | I | Dec-08-2016 |
| 2 | SynCardia Systems Inc. | I | Sep-17-2015 |