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.
Study Type
OBSERVATIONAL
Enrollment
1,400
Automated External Defibrillator
Philips
Monroeville, Pennsylvania, United States
RECRUITINGAlgorithm accuracy
Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.
Time frame: Up to 15 minutes after device placement
Shock Delivery
Percentage of events where a shock was delivered when indicated.
Time frame: 1 day
Unexpected adverse events.
Frequency and severity of unexpected adverse events.
Time frame: 1 day
Unanticipated adverse device effects (UADE)
Unanticipated adverse device effects (UADE)
Time frame: 1 day
Time Intervals
Measurements of device performance time intervals.
Time frame: 1 day
Device Preparation
Percentage of events where the device prepared to shock.
Time frame: 1 day
Shock Energy Delivered
The amount of shock energy delivered as measured in joules with each shock.
Time frame: 1 day
Pad Replacement
Frequency of pad replacement.
Time frame: 1 day
User
Frequency of user pressing the shock button.
Time frame: 1 day
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