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.
Study Type
OBSERVATIONAL
Enrollment
1,400
Automated External Defibrillator
Philips
Pittsburgh, Pennsylvania, United States
RECRUITINGMean 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 15 minutes during device placement
Defibrillation success
Defibrillation success and the number of shocks required for success.
Time frame: Up to 15 minutes during device placement
Frequency and severity of unexpected adverse events
Frequency and severity of unexpected adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 15 minutes during device placement
Unanticipated adverse device effects (UADE)
Unanticipated adverse device effects (UADE)
Time frame: Up to 15 minutes during device placement
Median operating time intervals
Median operating time intervals
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: Up to 15 minutes during device placement
CPR guidance initiated (i-button pushed)
Percentage of events where CPR guidance was initiated (i-button pushed)
Time frame: Up to 15 minutes during device placement
CPR activity
Percentage of events where CPR is performed during CPR guidance
Time frame: Up to 15 minutes during device placement