Events

Retiro De Equipo (Recall) de Device Recall LIFEPAK

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Physio Control Corp.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    27864
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0294-04
  • Fecha de inicio del evento
    2003-11-12
  • Fecha de publicación del evento
    2004-01-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-02-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30656
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    unknown device name - Product Code MKI
  • Causa
    Device unable to recognize the connection to the hard paddles accessory.
  • Acción
    Beginning on 11/12/03 representatives from the firm visited the consignees and replaced the paddles. A letter dated November 2003 was provided to the consignees.

Device

Device Recall LIFEPAK
  • Modelo / Serial
    Part numbers: 3200936-000, 3200936-001, 3200936-003, 3200936-010.   Date codes affected: 19680, 19681, or 19682  The firm shipped sets of paddles with shipments of devices with serial numbers listed. However, a set of paddles was not shipped specifically with each LP 20, and a customer may receive (per order) more devices than paddle sets. The paddles may be used with the devices specified below, or with any other LP 20 device. LP 20 serial numbers shipped: 31481310, 31487712, 31469046, 31480240, 31488466, 31488468, 31488472, 31488479, 31488482, 31488483, 31488485, 31488486, 31488487, 31488491, 31488492, 31488494, 31488495, 31488498, 31488499, 31488500, 31488502, 31488503, 31488505, 31488970, 31488971, 31488976, 31490835, 31490862, 31490864, 31490865, 31490914, 31492668, 31494830, 31494961, 31495055, 31496204, 31496499, 31496500, 31496502, 31497170, 31497171, 31497173, 30540237, 30541490, 30524326, 31405298, 31405302, 31406327, 31406328, 31406329, 31406330, 31407066, 31420549, 31461553, 31461548, 31461559, 31461565, 31451566, 31461568, 31461569, 31461575, 31461576, 31461578, 31461580, 31461583, 31469733, 31469741, 31469747, 31481173, 31481174, 31481261, 31481265, 31481277, 31481279, 31481281, 31490863, 31490913, 31491385, 31491387, 31491390, 31491441, 31491443, 31491445, 31491384, 31491388, 31491442, 31461579, 31491444, 31494875, 31494878, 31494883, 31494884, 31490836, 31492587, 31480230, 31488975, 31494882, 31488501, 31481264, 31409217, 31481262, 31412444, 31488474, 31488470, 31481152, 31481183, 31486080, 31486083, 31488340, 31488343, 31488344, 31495057, 31495686, 31499486, 31481318, 31488973, 31491581, 31469686, 31462754, 31461567, 31461555, 31461564, 31471398, 31462757, 31461558, 31469688, 31492591, 31461574, 31480226, 31462758, 31487665, 31469037, 31469038, 31469039, 31469041, 31469043, 31469044, 31469045, 31469689, 31469690, 31480222, 31480232, 31480234, 31480238, 31469678, 31469719, 31469707, 31469727, 31461560, 31481193, 31486082, 31487666, 31461570, 31469675, 31469677, 31469680, 31469682, 31469704, 31469709, 31469714, 31481269, 31491801, 31492056, 31492128, 31469711, 31469699, 31494874, 31461551, 31493149, 31471394, 31493147, 31480235, 31461577, 31462761, 31462768, 31469670, 31481321, 31488341, 31488342, 31488481, 31488489, 31488490, 31488493, 31488497, 31488504, 31488977, 31491065, 31491580, 31491803, 31492053, 31492588, 31492589, 31492590, 31492667, 31492669, 31493144, 31493146, 31493148, 31494428, 31494430, 31494433, 31494434, 31495056, 31495058, 31495059, 31495409, 31496498, 31501828, 31501829, 31469702, 31448168, 31461573, 31469710, 31469661, 31469684, 31496197, 31481313, 31469726, 31469730, 31462762
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    The firm distributed devices to 32 hospitals and medical centers located throughout the United States.
  • Descripción del producto
    LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.
  • Manufacturer
    Medtronic Physio Control Corp

Manufacturer

Medtronic Physio Control Corp
  • Dirección del fabricante
    Medtronic Physio Control Corp, 11811 Willows Rd NE, Redmond WA 98073
  • Source
    USFDA