Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment.

Detalles del retiro

Fabricante

Philips Medical Systems North America Inc.

Distribuidor

Worldwide Distribution - US Distribution including the states of AL, CA, CO, WA DC, FL, GA, HI, KS, MD, ME, MI, MS, NC, NM, NY, PA, TX, VA, WA and WI., and the countries of Australia, Austria, Canada, France, Germany, India, Italy, Ireland, Japan, Malaysia, Netherlands, Norway, Switzerland, Taiwan and United Kingdom.

Lote

Serial numbers of units distributed in the USA: C13A-00592, C13C-00131, C13C-00150, C13C-00270, C13C-00679, C13C-00681, C13C-00769, C13D-00048, C13D-00197, C13E-00088, C13E-00168, C13E-00234, C13E-00242, C13E-00245, C13E-00326, C13E-00340, C13E-00368, C13E-00372, C13E-00380, C13E-00382, C13E-00390, C13E-00406, C13E-00495, C13E-00507, C13E-00511, C13E-00516, C13E-00526, C13E-00537, C13F-00011, C13F-00012, C13F-00013, C13F-00022, C13F-00024, C13F-00027, C13F-00031, C13F-00032, C13F-00033, C13F-00035, C13F-00038, C13F-00043, C13F-00047, C13F-00053, C13F-00054, C13F-00059, C13F-00071, C13F-00077, C13F-00078, C13F-00102, C13F-00104, C13F-00110, C13F-00114, C13F-00118, C13F-00126, C13F-00131, C13F-00137, C13F-00138, C13F-00140, C13F-00143, C13F-00146, C13F-00148, C13F-00168, C13F-00172, C13F-00173, C13F-00174, C13F-00180, C13F-00181, C13F-00198, C13F-00202, C13F-00212, C13F-00214, C13F-00215, C13F-00217, C13F-00218, C13F-00224, C13F-00225, C13F-00227, C13F-00232, C13F-00233, C13F-00236, C13F-00238, C13F-00239, C13F-00240, C13F-00244, C13F-00246, C13F-00250, C13F-00255, C13F-00266, C13F-00273, C13F-00274, C13F-00275, C13F-00278, C13F-00284, C13F-00291, C13F-00294, C13F-00307, C13F-00309, C13F-00318, C13F-00321, C13F-00322, C13F-00323, C13F-00329, C13F-00330, C13F-00331, C13F-00332, C13F-00336, C13F-00348, C13F-00353, C13F-00468, C13F-00543, C13F-00559, C13F-00567, C13F-00578, C13F-00590, C13F-00593, C13F-00595, C13F-00599, C13F-00604, C13F-00607, C13F-00651, C13F-00778, C13G-00008, C13G-00010, C13G-00035, C13G-00056, C13G-00057, C13G-00282, C13G-00284, and C13H-00062. Serial numbers of units outside the USA: C13C-00004, C13C-00256, C13C-00305, C13C-00323, C13C-00608, C13C-00639, C13E-00009, C13E-00021, C13E-00036, C13E-00048, C13E-00057, C13E-00058, C13E-00065, C13E-00163, C13E-00250, C13E-00265, C13E-00273, C13E-00311, C13E-00323, C13E-00328, C13E-00339, C13E-00341, C13E-00345, C13E-00346, C13E-00349, C13E-00350, C13E-00351, C13E-00358, C13E-00393, C13E-00395, C13E-00404, C13E-00407, C13E-00409, C13E-00424, C13E-00437, C13E-00441, C13E-00452, C13E-00454, C13E-00455, C13E-00499, C13E-00503, C13E-00518, C13E-00527, C13E-00535, C13E-00548, C13F-00010, C13F-00280, C13F-00286, C13F-00293, C13F-00298, C13F-00302, C13F-00303, C13F-00305, C13F-00306, C13F-00316, C13F-00317, C13F-00343, C13F-00345, C13F-00346, C13F-00358, C13F-00363, C13F-00369, C13F-00371, C13F-00381, C13F-00385, C13F-00391, C13F-00400, C13F-00420, C13F-00424, C13F-00428, C13F-00436, C13F-00473, C13F-00498, C13F-00539, C13F-00565, C13F-00579, C13F-00580, C13F-00583, C13F-00586, C13F-00587, C13F-00606, C13F-00619, C13F-00627, C13F-00629, C13F-00649, C13F-00666, C13F-00668, C13F-00677, C13F-00678, C13F-00682, C13F-00685, C13F-00687, C13F-00726, C13F-00742, C13F-00746, C13F-00748, C13F-00755, C13F-00758, C13F-00760, C13F-00782, C13F-00797, C13F-00815, C13F-00870, C13F-00889, C13F-00896, C13F-00938, C13G-00026, C13G-00039, C13G-00084, C13G-00126, C13G-00132, C13G-00142, C13G-00237, C13G-00247, C13G-00293, C13G-00315, C13G-00331, C13G-00337, C13G-00345, C13G-00407, C13G-00435, C13G-00451, and C13H-00035.

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States