| Device Type ID | 752 |
| Device Name | Compressor, Cardiac, External |
| Regulation Description | External Cardiac Compressor. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 752 |
| Device | Compressor, Cardiac, External |
| Product Code | DRM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Cardiac Compressor. |
| CFR Regulation Number | 870.5200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEFIBTECH, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JOHNSON & JOHNSON | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 1150 |
Visual Prompts Will Not Clear | 1102 |
Device Operational Issue | 832 |
Device Operates Differently Than Expected | 481 |
Battery Problem | 136 |
Device Stops Intermittently | 111 |
Failure To Power Up | 90 |
No Display / Image | 85 |
Use Of Device Problem | 59 |
Low Battery | 57 |
Device Issue | 54 |
Adverse Event Without Identified Device Or Use Problem | 46 |
Positioning Failure | 31 |
Activation, Positioning Or Separation Problem | 22 |
Connection Problem | 21 |
Charging Problem | 13 |
Loss Of Power | 12 |
Display Or Visual Feedback Problem | 12 |
Device Inoperable | 11 |
Failure To Charge | 8 |
Erratic Or Intermittent Display | 6 |
Loose Or Intermittent Connection | 6 |
Break | 5 |
Display | 4 |
Protective Measures Problem | 4 |
No Apparent Adverse Event | 4 |
Battery | 4 |
Power Problem | 4 |
Premature Discharge Of Battery | 3 |
Overheating Of Device | 3 |
No Device Output | 2 |
Poor Quality Image | 2 |
Difficult Or Delayed Positioning | 2 |
Failure To Run On Battery | 2 |
Therapeutic Or Diagnostic Output Failure | 2 |
Unknown (for Use When The Device Problem Is Not Known) | 2 |
Issue With Displayed Error Message | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Failure To Sense | 2 |
Bent | 1 |
Device Component Or Accessory | 1 |
Display Difficult To Read | 1 |
Retraction Problem | 1 |
Physical Property Issue | 1 |
Inadequate Storage | 1 |
Output Below Specifications | 1 |
Screen | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Fitting Problem | 1 |
Arcing | 1 |
Failure Of Device To Self-Test | 1 |
Image Display Error / Artifact | 1 |
Device Handling Problem | 1 |
Installation-Related Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Panel | 1 |
Crack | 1 |
Failure To Disconnect | 1 |
Belt | 1 |
| Total Device Problems | 4415 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Michigan Instruments, Inc. | III | May-04-2018 |
| 2 | Zoll Circulation, Inc. | III | Jul-22-2014 |