Devices

Lifepak 12

Fabricant

Medtronic Physio-Control Inc.
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    SATP

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Device Recall LIFEPAK 12 Defibrillator/Monitor
  • Modèle / numéro de série
    LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544.  SERIAL NUMBERS OF DEVICES:  32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
  • Description du dispositif
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. || The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). || The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
  • Manufacturer
    Physio-Control, Inc.
Device Recall LIFEPAK 12
  • Modèle / numéro de série
    Each unit is given a unique serial number. All LIFEPAK 12 units are affected.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution, including government/military accounts.
  • Description du dispositif
    LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to externally pace, manually defibrillate, or automatically analyze and if necessary, defibrillate a patient through therapy cables with disposable electrodes, standard paddles, or internal handle cables. Product is labeled with ''Medtronic Physio-Control, Redmond, WA''
  • Manufacturer
    Medtronic Physio Control Corp
Device Recall LIFEPAK 12
  • Modèle / numéro de série
    VLP12-02 Part Numbers all with a Biphasic label on the front of the device
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    28,835 devices were shipped to 6874 domestic consignees.
  • Description du dispositif
    LIFEPAK 12 defibrillator/ monitors biphasic
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.
Device Recall LIFEPAK 12
  • Modèle / numéro de série
    Domestic Serial Numbers: 34106383, 33996555, 33992033, 33992030, 33992029, 33992031, 33992027, 33990244, 33990241, 33990245, 33990242, 33990240, 34096406, 34086957, 34039438, 34100891, 33917921, 34100498, 34019560, 34011939, 34011940, 33985062, 33985063, 33985064, 33985065, 33985066, 33985067, 33985068, 33985070, 33985069, 33985074, 33985061, 33985071, 33985073, 33915256, 34016156, 34016153, 34016154, 34016155, 34016157, 34016158, 33989218, 33989220, 33989216, 33989219, 33989217, 34039448, 34048193, 34100900, 34020194, 34020192, 34060159, 33988136, 33988137, 34020193, 33995357, 33949669, 34074066, 33913884, 34014205, 11201950, 34091725, 34064561, 33913893, 33913894, 33913895, 34004873, 33995317, 33995318, 33995316, 33995315, 33995319, 34064439, 34064440, 34064441, 34020190, 34020507, 34020187, 34020189, 34020188, 34019563, 34019572, 34019573, 33904159, 33905092, 34095289, 34095297, 34095301, 33991999, 33992000, 33992003, 33992023, 33992028, 33992016, 33991998, 34087619, 34087620, 34087605, 34087610, 34087612, 34087035, 34087892, 34087602, 34087615, 34087616, 34087617, 34087618, 34086700, 34086709, 34086715, 34087613, 34086714, 34087609, 34087607, 34087614, 34087608, 34086718, 34086706, 34086719, 34086711, 34086713, 34086705, 34086717, 34086702, 34087606, 34086703, 34087033, 34086708, 34086712, 34087603, 34086707, 34087604, 34086716, 34087601, 34087034, 34091720, 33949930, 34091120, 34039430, 34039429, 34015786, 34011974, 33982989, 33899585, 33995356, 33995351, 33995350, 33995346, 33995360, 33995355, 33995369, 33995349, 33995348, 33995352, 33995347, 33995359, 33995353, 33995345, 33995358, 33995354, 12737672, 33913878, 34094631, 34049603, 34049601, 34049604, 34049611, 34049606, 34049607, 34049609, 34049612, 34049608, 34049610, 34049605, 34049602, 30859396, 33978921, 33978922, 33978923, 33978924, 34039468, 34039433, 34039470, 34083705, 34096379, 33915357, 33988150, 33992032, 33931367, 33931365, 33931364, 33931363, 33931362, 33931366, 34052702, 34052703, 33795379, 34095303, 34095298, 34095299, 34095304, 34095300, 34096375, 34095314, 34095313, 34095312, 34095307, 34095306, 34095305, 33862271, 34019587, 34020177, 34019586, 34019585, 34090338, 34090337, 34049130, 34043663, 34086675, 34086676, 34086671, 34086672, 34086674, 34086673, 33832318, 33888386, 33888372, 33888377, 33888376, 33888378, 33888379, 33888383, 33888385, 33888384, 33888373, 34044798, 34064654, 34019555, 34019554, 33802295, 33990042, 33982418, 33982417, 34074060, 34074061, 34095296, 34039463, 33950592, 33983052, 34099021, 34095323, 34082638, 34078647, 34078648, 34078646, 34082590, 34082591, 34048199, 34048200, 34049140, 34049141, 34048196, 34048198, 34045124, 34048194, 34010325, 33899587, 34096386, 34074089, 33974887, 33974888, 34078076, 34100491, 34100492, 34099179, 34099180, 34099178, 34099177, 34099176, 34090571, 34067899, 33995913, 33995914, 33974374, 33974373, 34013030, 34083205, 34019584, 10732394, 10732404, 34079488, 34084291, 34084290, 34004900, 34019558, 34019561, 33913867, 33913879, 33913888, 33995281, 33995280, 34090554, 34090556, 34090555, 34052280, 33991462, 34065273, 34048197, 34048195, 34034132, 34004904, 34082921, 34060126, 34060127, 34060128, 34086704, 34086701, 34086710, 33992506, 34074081, 34074073, 33855207, 33995302, 33995301, 34054626, 34054625, 33904163, 12776983, 33997196, 33987972, 33987973, 33928602, 34010320, 33974366, 34095302, 33938189, 34040207, 34039481, 34060174, 34060158, 34060161, 34060160, 34064667, 34003616, 34039469, 34060746, 34034134, 34106173, 33995035, 34074053, 34010323, 34090366, 34087611, 34090303, 34090302, 34091128, 34091129, 34095293, 33897593, 34078783, 34078784, 34078785, 34074072, 33992007, 33992020, 33993956, 33992022, 33992002, 33992021, 33992024, 33992025, 33992026, 33992004, 33992009, 33992015, 33992001, 33990248, 33992006, 33992005, 33992008, 33992014, 33992018, 33992017, 33990243, 33990246, 33990247, 33992011, 33992012, 33992013, 33992019, 33992010, 34019904, 33899702, 33960797, 33960796, 33960799, 33960798, 33960795, 33995049, 34061036, 34090589, 33931359, 33931358, 33931355, 33931356, 33931357, 34079490, 34079489, 34079833, 34079492, 34079491, 34079487, 34079486, 34079485, 33936114, 34068040, 34068041, 34078675, 33925842, 33925844, 33925846, 33925841, 33925843, 33925845, 33935283, 33935282, 33935281, 33935280, 33928109, 34090546, 34039464, 34082588, 33911101, 33911100, 33965863, 34074054, 34070493, 33997671, 33997672, 34078070, 34064659, 33996557, 33996553, 33996551, 33996550, 33996556, 33996549, 33996849, 33996558, 33996554, 33996552, 33993444, 34095321, 34095327, 34095331, 34095330, 34095326, 34095329, 34095320, 34095324, 34095328, 34095322, 33983339, 33976090, 33983346, 33983345, 33983338, 33983337, 33983336, 33983335, 32525390, 33995263, 34020191, 34019826, 34019557, 34019827, 34019556, 13583628, 34005592, 34005591, 34005587, 34005588, 34005589, 34005590, 33969580, 33969582, 33969581, 33969583, 33969584, 33995222, 34045762, 34099186, 34099185, 33991446, 33903858, 33997197, 34084471, 34075613, 34075614.    International Serial Numbers: 34098600, 34098601, 34090290, 34049509, 34049514, 34049515, 34083701, 34083702, 34044802, 33982442, 33982438, 33982439, 33934527, 33903205, 33903206, 33903208, 33903204, 33903198, 33903203, 33903207, 33903201, 33903210, 33903202, 33903199, 33903200, 33934528, 33934531, 33934529, 33934526, 33934530, 33928168, 33903217, 33928174, 33928165, 33982454, 33982437, 33982443, 33982440, 33903216, 33903215, 33982453, 33982452, 33982451, 33982450, 33982441, 33982448, 33982447, 33982446, 33982445, 33982444, 33982449, 33903209, 33928169, 33928160, 33928161, 33928162, 33928164, 33928170, 33928171, 33928172, 33928173, 33928175, 33928176, 33928177, 33928167, 33903211, 33903212, 33903213, 33903214, 33928159, 33950039, 33950038, 33950048, 33952773, 33952774, 33952775, 33952771, 34105152, 33950032, 33876945, 33876930, 33821315, 33876931, 34078216, 33876941, 33876943, 33876942, 33876938, 33876944, 33876952, 33876928, 33876946, 33876951, 33876950, 33876948, 33876940, 33876933, 33876935, 33876936, 33876937, 33950037, 33929937, 33950034, 33950043, 33950042, 33950041, 33950040, 33950053, 33950052, 33950051, 33950049, 33950045, 33950046, 33950047, 33950035, 33950050, 33950054, 33876949, 33876947, 33876939, 33876934, 33876932, 34079098, 33876929, 33950044, 33950033, 33950031, 33950030, 33950036, 34078082, 34078078, 34078081, 34078080, 34079097, 34083393, 34078079, 33985301, 33985300, 33985299, 33985307, 33986568, 33952772, 34079096, 34078215, 34078217, 34078225, 33982471, 33985298, 33985303, 33985304, 33986537, 33985302, 34009595, 34009594, 34009593, 34083729, 34083732, 34077752, 34106204, 34091376, 13669402, 33928605, 33985022, 33983183, 33979582, 33979583, 33974289, 33974293, 33952829, 33952830, 33798619, 33913915, 33798616, 33913909, 33918168, 33918735, 33918736, 33872713, 33918165, 33918166, 33918167, 33918181, 33795390, 33798614, 33896029, 33887441, 33798612, 33795399, 33795397, 33932561, 34094348, 34094349, 34091746, 33986283, 34039425, 33986294, 33983009, 33795389, 33983184, 33983178, 33983010, 33961531, 34074827, 34087714, 33974286, 34049521, 34049526, 34049527, 34049528, 34049529, 34049530, 34053704, 34049523, 33913897, 33913904, 34008743, 34008737, 34003664, 34003634, 34020680, 34020681, 34020164, 34020510, 34034118, 34034725, 33983556, 33974288, 33974287, 33979581, 33974290, 33974291, 34049522, 33983555, 33983554, 33979580, 33974229, 33974292, 33986320, 33913913, 34049520, 33986261, 33974295, 34053733, 34049525, 34053699, 34049524, 33913899, 33913900, 33913901, 33913902, 33985306, 33913905, 34069183, 33985305, 33913898, 33913903, 33913906, 33986313, 33986285, 34003817, 34049519, 34003650, 34003796, 34004911, 34008686, 34008744, 34008742, 34008740, 34008739, 34008738, 34008687, 34008745, 34008741, 34003658, 34020516, 34084458, 34084468, 34074427, 34084092, 34087711, 34087496, 33937399, 33937400, 33937398, 34090742, 33937401, 33937404, 34074835, 33937402, 34083715, 33937403, 33937397, 34090743, 33937405, 33910410, 33910411, 34090741, 34083714, 34044811, 34044812, 34039416, 34074102, 33979590, 34074107, 33983550, 34039419, 34073371, 34039413, 33958404, 33958774, 34074106, 33855054, 33921591, 33921592, 33880013, 33880012, 33880011, 33895654, 33900603, 33899646, 33895655, 33961098, 33961097, 33978886, 34074101, 34106223, 33973952, 33978885, 33979004, 33978888, 33978887, 33983551, 34039415, 34039409, 34039408, 33979564, 33979567, 34079036, 33895653, 33895652, 33895651, 33895650, 33895649, 33893664, 33892562, 33945926, 34074108, 34064246, 34039418, 33895656, 34064247, 34074105, 33968953, 34074099, 34074595, 34074596, 34074104, 34074098, 33949217, 33968972, 33969016, 34074103, 34008392, 34039421, 34012451, 34039422, 34040777, 34040525, 33969015, 34039406, 33968973, 34039405, 33968970, 33968962, 33968966, 33968964, 33969014, 34039407, 33968968, 34034122, 34034124, 34034127, 34034129, 34073370, 33983559, 34073365, 34073366, 34073376, 34065724, 34073364, 33905086, 33905087, 33905088, 33905089, 34003929, 34073369, 34073372, 34073373, 34073374, 34073375, 33968961, 33968963, 33983561, 34079035, 34043644, 34079040, 34079039, 34079037, 34073368, 34073367, 34073363, 34079038, 33928097, 34039410, 34043602, 33983560, 34039411, 34039412, 34043601, 34039414, 33928392, 33968957, 33968956, 33968955, 33968954, 34004876, 34043599, 34044807, 34004928, 34004927, 33968971, 34039417, 34003928, 34004922, 34004924, 34039423, 33968959, 34106425, 34106224, 34106225, 34086724, 34091392, 34086725.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics,
  • Description du dispositif
    LIFEPAK 12 defibrillator/monitor
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.
Monitor / defibrillator LIFEPAK 12 and LIFEPAK 15, with final expiratory CO2 function (EtCO2), mo...
  • Modèle / numéro de série
  • Manufacturer
    N/A
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