| Device Type ID | 754 |
| Device Name | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Regulation Description | External Transcutaneous Cardiac Pacemaker (noninvasive). |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Implantable Electrophysical Devices Branch (IEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 754 |
| Device | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Product Code | DRO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Transcutaneous Cardiac Pacemaker (noninvasive). |
| CFR Regulation Number | 870.5550 [🔎] |
| Device Problems | |
|---|---|
Pacing Problem | 109 |
Device Displays Incorrect Message | 59 |
Failure Of Device To Self-Test | 40 |
Gel Leak | 16 |
Output Problem | 12 |
Energy Output Problem | 7 |
Connection Problem | 6 |
Delamination | 5 |
Device Operates Differently Than Expected | 5 |
Device Operational Issue | 5 |
Failure To Capture | 4 |
No Pacing | 4 |
Defibrillation Problem | 4 |
Material Separation | 4 |
Unable To Obtain Readings | 3 |
Improper Alarm | 2 |
Output Below Specifications | 2 |
Electrical /Electronic Property Problem | 2 |
Output Above Specifications | 2 |
Appropriate Term/Code Not Available | 2 |
Arcing Of Electrodes | 2 |
Capturing Problem | 2 |
Failure To Read Input Signal | 2 |
Device Sensing Problem | 1 |
Improper Device Output | 1 |
Material Integrity Problem | 1 |
Failure To Adhere Or Bond | 1 |
Inappropriate Shock | 1 |
Programming Issue | 1 |
Pacing Inadequately | 1 |
Inaccurate Synchronization | 1 |
Signal Artifact | 1 |
Failure To Charge | 1 |
No Display / Image | 1 |
Inappropriate Or Unexpected Reset | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Physical Resistance / Sticking | 1 |
Incomplete Or Inadequate Connection | 1 |
Peeled / Delaminated | 1 |
Sensing Intermittently | 1 |
Loss Of Power | 1 |
Failure To Power Up | 1 |
Noise, Audible | 1 |
Detachment Of Device Or Device Component | 1 |
Inadequate User Interface | 1 |
| Total Device Problems | 321 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Covidien LLC | II | Sep-02-2015 |
| 2 | Covidien LLC | I | Oct-15-2014 |