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A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) & HeartStart Home (Model M5068A) Defibrillator device data.
The objective of this PMCF (Post Market Clinical Follow-up) prospective collection of post-event data registry is to confirm the safety and performance as expressed in the energy delivery by the HeartStart HS1 Defibrillator (HeartStart OnSite and Home models in North America) in the population for the device's intended use in reference to its commercial labeling, and in relationship to the type of pads attached to the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected Sudden Cardiac Arrest | All subjects with suspected of a circulatory arrest of any cause. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartStart HS1 | Device | Automated External Defibrillator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean shock energy delivered in the pediatric population | Mean of shock energy delivered, when the pediatric defibrillation pads were attached to the AED as intended for infants and children under 25 kilograms / 55 pounds or 0-8 years old. | Up to 15 minutes during device placement |
| Mean shock energy delivered in the adult population | Mean of shock energy delivered, when the adult defibrillation pads were attached to the AED as intended for in children and adults over 25 kilograms / 55 pounds or greater than 8 years old. | Up to 15 minutes during device placement |
| The Patient Analysis System (PAS) shock advisory algorithm performance as determined by evaluation of the ECG as aligned with the device advisement. | Performance is defined by the sensitivity and specificity; positive predictive value and false positive rate will be reported for each rhythm category (as defined by device labeling). | Up to 15 minutes during device placement |
| Accurate detection of shockable rhythms and facilitation of shocks. | The percentage of events where a shockable rhythm was identified by the device, the device advised a shock, and the device delivered a shock when the shock button was pressed. | Up to 15 minutes during device placement |
| Defibrillation success | Defibrillation success and the number of shocks required for success. | Up to 15 minutes during device placement |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of unexpected adverse events | Frequency and severity of unexpected adverse events | Up to 15 minutes during device placement |
| Unanticipated adverse device effects (UADE) | Unanticipated adverse device effects (UADE) |
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Inclusion Criteria:
Adult SMART Pads Cartridge [REF: M5071A], Infant/Child SMART Pads Cartridge (REF:M5072A) applied to their body and powered up with HS1 battery (Model M5070A), regardless of whether a defibrillation shock was delivered
Exclusion Criteria:
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Anyone who is suspected of having a sudden cardiac arrest.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chase Wennick | Contact | 617-398-7347 | chase.wennick@philips.com | |
| Barbara Fink | Contact | 724-708-7048 | barb.fink@philips.com |
| Name | Affiliation | Role |
|---|---|---|
| Gerrit Noordergraaf, MD PhD | Philips Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philips | Recruiting | Pittsburgh | Pennsylvania | 15206 | 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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| Up to 15 minutes during device placement |
| Median operating time intervals | Median operating time intervals | Up to 15 minutes during device placement |
| Routine self-test performance/Battery Insertion self-test performance | Routine self-test performance/Battery Insertion self-test performance | Up to 15 minutes during device placement |
| Device arming after shock advisement. | The percentage of events where the device advised a shock and the device armed. | Up to 15 minutes during device placement |
| Energy delivered consistent with device labeling | The percentage of defibrillations in which the energy delivered was consistent with device labeling. | Up to 15 minutes during device placement |
| Pad replacement notification | Number of events in which pads were replaced at any time during the event after the user is prompted to do so by the device | Up to 15 minutes during device placement |
| Shock button effectively pressed after shock advisement | The percentage of events where a shock was recommended by the device and the shock button was pressed. | Up to 15 minutes during device placement |
| Indicators of battery status/depletion (device logged data) | Percentage of events that include indicators of battery status/depletion (device logged data) | Up to 15 minutes during device placement |
| Aborted shocks because of low or high impedance | Percentage of aborted shocks because of low or high impedance | Up to 15 minutes during device placement |
| CPR guidance initiated (i-button pushed) | Percentage of events where CPR guidance was initiated (i-button pushed) | Up to 15 minutes during device placement |
| CPR activity | Percentage of events where CPR is performed during CPR guidance | Up to 15 minutes during device placement |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |