| Device Type ID | 768 |
| Device Name | Detector And Alarm, Arrhythmia |
| Regulation Description | Arrhythmia Detector And Alarm (including ST-segment Measurement And Alarm). |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1025 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DSI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 768 |
| Device | Detector And Alarm, Arrhythmia |
| Product Code | DSI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Arrhythmia Detector And Alarm (including ST-segment Measurement And Alarm). |
| CFR Regulation Number | 870.1025 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRAEMAR CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORCAM TECHNOLOGIA, SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORVENTIS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBAL INSTRUMENTATION, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTELESENS LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IRHYTHM TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFEWATCH TECHNOLOGIES LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICALGORITHMICS S.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDICOMP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICOMP INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
MENNEN MEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PREVENTICE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCOTTCARE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE SCOTT FETZER CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITASYSTEMS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Under-Sensing | 2839 |
Premature Discharge Of Battery | 2620 |
Over-Sensing | 1775 |
Migration Or Expulsion Of Device | 538 |
Invalid Sensing | 485 |
Signal Artifact | 450 |
Device Sensing Problem | 350 |
Failure To Interrogate | 259 |
Unable To Obtain Readings | 245 |
Adverse Event Without Identified Device Or Use Problem | 230 |
Decreased Sensitivity | 175 |
Battery Problem | 170 |
Appropriate Term/Code Not Available | 117 |
Reset Problem | 110 |
Communication Or Transmission Problem | 105 |
Incorrect Measurement | 87 |
Device Operates Differently Than Expected | 79 |
Inappropriate Or Unexpected Reset | 51 |
Positioning Problem | 37 |
Electromagnetic Interference | 35 |
Device Alarm System | 31 |
Device Displays Incorrect Message | 25 |
False Positive Result | 22 |
Output Problem | 22 |
No Device Output | 17 |
Component Missing | 15 |
No Audible Alarm | 15 |
No Display / Image | 14 |
Data Problem | 12 |
No Audible Prompt / Feedback | 12 |
Failure To Power Up | 12 |
Battery Impedance Issue | 11 |
Device Expiration Issue | 11 |
Break | 7 |
Insufficient Information | 7 |
Device Stops Intermittently | 6 |
Device Operational Issue | 6 |
Difficult To Remove | 4 |
Device Inoperable | 4 |
Device Dislodged Or Dislocated | 4 |
Connection Problem | 4 |
Electrical /Electronic Property Problem | 4 |
Computer Operating System Problem | 4 |
Monitor | 4 |
Device-Device Incompatibility | 3 |
Loss Of Power | 3 |
Protective Measures Problem | 3 |
Speaker | 3 |
Device Difficult To Program Or Calibrate | 3 |
Use Of Device Problem | 3 |
Circuit Failure | 2 |
Material Integrity Problem | 2 |
Switch, Push Button | 2 |
Housing | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Disconnection | 2 |
Mechanical Problem | 2 |
Overheating Of Device | 2 |
Inaudible Or Unclear Audible Prompt / Feedback | 2 |
Device Contamination With Chemical Or Other Material | 1 |
Device Maintenance Issue | 1 |
Device Packaging Compromised | 1 |
Battery Problem: High Impedance | 1 |
Application Network Problem | 1 |
Radio Signal Problem | 1 |
Device Emits Odor | 1 |
Packaging Problem | 1 |
Display Or Visual Feedback Problem | 1 |
Display | 1 |
Loose Or Intermittent Connection | 1 |
Moisture Damage | 1 |
Alarm | 1 |
Failure To Capture | 1 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 |
Energy Output Problem | 1 |
Loss Of Data | 1 |
Issue With Displayed Error Message | 1 |
Patient-Device Incompatibility | 1 |
Operating System Becomes Nonfunctional | 1 |
False Reading From Device Non-Compliance | 1 |
PC (Printed Circuit) Board | 1 |
Bent | 1 |
Cannula | 1 |
No Apparent Adverse Event | 1 |
Activation, Positioning Or Separation Problem | 1 |
| Total Device Problems | 11092 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Inc. | II | Mar-25-2016 |
| 2 | Philips Electronics North America Corporation | II | Dec-10-2018 |
| 3 | Philips Electronics North America Corporation | II | Jun-11-2018 |
| 4 | Philips Electronics North America Corporation | II | Apr-04-2017 |
| 5 | Scottcare Corporation | II | Apr-01-2016 |
| 6 | Spacelabs Healthcare Inc | II | Aug-04-2016 |
| 7 | Spacelabs Healthcare Inc | II | May-04-2015 |
| 8 | Spacelabs Healthcare Inc | II | Apr-28-2015 |
| 9 | Spacelabs Healthcare Inc | II | Jun-03-2014 |