AED Log Analysis of 19 Cases in Out-of-hospital Environment

RadianQbio

Status: Completed

Conditions: Cardiac Arrest, Sudden

Treatments: Device: RADIAQBIO Heart Guardian HR-501

Study type: Observational

Funder types: Industry

Identifiers

NCT03969797

HR501_20190527

Details and patient eligibility

About

The study performed to demonstrate a reasonable assurance of safety and effectiveness of the Heart Guardian HR-501 when used in an out-of-hospital environment.

Full description

The defibrillation study was conducted by analyzing the logs of Heart Guardian HR-501 with Radian ECG Viewer. The product analysis was studied whether the device was operated normally in ECG analysis and electric shocks.

Enrollment: 19 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• out-of-hospital cardiac arrest
• > 12 months

Exclusion criteria

• age under 12 months