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This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected Sudden Cardiac Arrest | All subject with suspected of a circulatory arrest for any cause. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartStart FRX | Device | Automated External Defibrillator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Algorithm accuracy | Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement. | Up to 15 minutes after device placement |
| Shock Delivery | Percentage of events where a shock was delivered when indicated. | 1 day |
| Unexpected adverse events. | Frequency and severity of unexpected adverse events. | 1 day |
| Unanticipated adverse device effects (UADE) | Unanticipated adverse device effects (UADE) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Time Intervals | Measurements of device performance time intervals. | 1 day |
| Device Preparation | Percentage of events where the device prepared to shock. |
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Inclusion Criteria:
Exclusion Criteria:
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Use of the HeartStart FRx AED is intended for the following populations in addition to adults: newborns, neonates, infant, children, and adolescents. It may also be used on pregnant women. Devices are located in public access spaces and with first responders around the world.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barb Fink | Contact | 724-708-7048 | barb.fink@philips.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philips | Recruiting | Monroeville | Pennsylvania | 15146 | United States |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| 1 day |
| Shock Energy Delivered | The amount of shock energy delivered as measured in joules with each shock. | 1 day |
| Pad Replacement | Frequency of pad replacement. | 1 day |
| User | Frequency of user pressing the shock button. | 1 day |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |