HeartStart HS1 Defibrillator* Event Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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HeartStart HS1 Defibrillator* Event Registry

Conditions
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Sudden Cardiac Arrest

Intervention / Treatment
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* Device: HeartStart HS1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been suspected of a circulatory arrest for any cause. Have had HeartStart HS1 Defibrillator with electrodes: 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: Subjects will be excluded if any of the following are present: AED or pad use other than the HeartStart HS1 Defibrillator with above referenced Philips electrode pads. Note: Use of a device other than the Philips HeartStart HS1 AED does not preclude enrollment if the AED or an Advanced Life Support defibrillator was used after the HeartStart HS1 AED. AED used for training purposes.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected Sudden Cardiac Arrest<br>All subjects with suspected of a circulatory arrest of any cause. | Device: HeartStart HS1<br>* Automated External Defibrillator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post -Market, Cardiology, AED