Retiro De Equipo (Recall) de LIFEPAK 15 MONITOR/DEFIBRILLATOR

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 Physio Control, Inc..

¿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
    53087
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2110-2009
  • Fecha de inicio del evento
    2009-08-12
  • Fecha de publicación del evento
    2009-09-18
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Automated external defibrillators (non-wearable) - Product Code DXN
  • Causa
    Some lifepak 15 monitor/defibrillators have a non-invasive blood pressure (nibp) module that was supplied by cas medical systems, branford, connecticut who is recalling the modules. the nibp modules may be susceptible to sudden changes in cuff pressure. sudden changes in cuff pressure may possibly be caused by bumping or squeezing the cuff. in some instances this may result in a screen display.
  • Acción
    The firm notified customers by letter dated August 2009. Customers will have the Noninvasive Blood Pressure (NIBP) module replaced. If additional questions about the notification, contact Technical Support by calling 1-800-442-1142, option 5, Monday-Friday 6:00 a.m. to 4:00 p.m. (Pacific Standard Time). .

Device

  • Modelo / Serial
    Serial numbers are various and non-contiguous:  Domestic Device SN, 37937856, 37937866, 37963295, 37963300, 37963302, 37963322, 37963323, 37963328, 37924152, 37968424, 37968429, 37968715, 37968716, 37968717, 37968718, 37968721, 37968722, 37968724, 37923203, 37923213, 37964622, 37976542, 37976544, 37976545, 37976551, 37923162, 37923205, 37923208, 37923100, 37870245, 37924157, 37937888, 37923079, 37923153, 37923078, 37924153, 37963927, 37964561, 37928794, 37933262, 37930942, 37930944, 37930946, 37930964, 37930966, 37930977, 37930986, 37930988, 37930989, 37930990, 37930993, 37933240, 37933241, 37933244, 37937843, 37937846, 37937847, 37937848, 37937849, 37937850, 37937854, 37937855, 37937862, 37937870, 37937871, 37937873, 37937885, 37937886, 37937887, 37937891, 37937892, 37963929, 37964567, 37964592, 37963324, 37964615, 37964559, 37964585, 37964610, 37963935, 37968422, 37963932, 37964557, 37964569, 37964628, 37963931, 37964621, 37964630, 37968425, 37933257, 37963928, 37963325, 37963930, 37964591, 37964596, 37964587, 37964554, 37964609, 37964560, 37963926, 37964564, 37964626, 37964618, 37964600, 37964601, 37964607, 37963329, 37964594, 37963923, 37963327, 37963292, 37964613, 37964608, 37964575, 37964589, 37964623, 37964565, 37964588, 37964617, 37964599, 37964614, 37968427, 37928964, 37933267, 37930962, 37930968, 37930987, 37931003, 37933246, 37933249, 37933250, 37937842, 37937852, 37937864, 37937865, 37937867, 37937872, 37937874, 37937881, 37937883, 37937889, 37937890, 37937894, 37937896, 37964552, 37937851 International Consignees Device SN, 37937845, 37937869, 37937884, 37937893, 37937895, 37963250, 37968304, 37445046, 37799902, 37799911, 37799913, 37799914, 37799915, 37800767, 37800768, 37800769, 37800771, 37803641, 37803642, 37803643, 37803644, 37803645, 37803646, 37803647, 37803648, 37803650, 37803651, 37804604, 37804605, 37804606, 37804607, 37804615, 37805136, 37805137, 37805138, 37805139, 37805140, 37805141, 37805142, 37805143, 37805144, 37805145, 37805146, 37805147, 37805148, 37805149, 37805150, 37805151, 37805152, 37805153, 37805154, 37805155, 37805156, 37805157, 37805158, 37805159, 37805160, 37805161, 37805162, 37805163, 37805164, 37805165, 37805166, 37805167, 37805168, 37805169, 37805170, 37805171, 37805172, 37805173, 37805174, 37805182, 37805183, 37805184, 37805185, 37805186, 37805187, 37805188, 37805189, 37805190, 37805191, 37805192, 37805193, 37805194, 37805195, 37805196, 37805197, 37805198, 37805199, 37805200, 37805201, 37805202, 37808586, 37808587, 37808588, 37808589, 37808590, 37808591, 37808592, 37808593, 37808594, 37808595, 37808596, 37808597, 37808598, 37808599, 37808600, 37810775, 37810776, 37810777, 37810778, 37810779, 37810780, 37810781, 37810782, 37810783, 37810784, 37810785, 37810786, 37810787, 37810788, 37810789, 37810819, 37810820, 37810821, 37810823, 37869808, 37869810, 37869811, 37869812, 37869814, 37869816, 37869817, 37869818, 37869820, 37869821, 37869822, 37869823, 37869824, 37869827, 37869828, 37869829, 37870210, 37870211, 37870213, 37870214, 37870215, 37870216, 37870217, 37870218, 37870219, 37870220, 37870221, 37870222, 37870223, 37870224, 37870225, 37870226, 37870228, 37870229, 37870236, 37870246, 37870247, 37870249, 37870250, 37870251, 37870252, 37870254, 37870255, 37870256, 37870258, 37870259, 37870260, 37900520, 37900602, 37900603, 37900604, 37900605, 37900607, 37900608, 37900610, 37900611, 37900612, 37900615, 37900616, 37900617, 37900618, 37900621, 37900622, 37900623, 37900624, 37900625, 37900626, 37900628, 37900629, 37900630, 37900631, 37900632, 37900633, 37923087, 37923112, 37923125, 37923155, 37923156, 37923201, 37923202, 37923204, 37923206, 37923210, 37923211, 37923214, 37924154, 37924156, 37924160, 37924163, 37924165, 37928454, 37928456, 37928457, 37928458, 37928459, 37928460, 37928461, 37928462, 37928463, 37928790, 37928791, 37928792, 37928793, 37928958, 37928967, 37933252, 37933253, 37933254, 37933259, 37933260, 37933261, 37933263, 37933264, 37933265, 37933266, 37933268, 37933269, 37933270, 37928968, 37930948, 37930960, 37930970, 37930976, 37930983, 37930984, 37930991, 37930994, 37930995, 37930997, 37930999, 37931000, 37931001, 37931005, 37933237, 37933238, 37933242, 37933245, 37933247, 37933248, 37933275, 37933276, 37933277, 37933280, 37937844, 37963303, 37968306, 37869809, 37869815, 37869825, 37869826, 37870212, 37923207, 37924155, 37924164, 37928455, 37928960, 37928961, 37933256, 37930940, 37930953, 37930972, 37930974, 37930979, 37930982, 37930992, 37930996, 37931004, 37933243, 37933251, 37933271, 37933273, 37933278, and 37933279.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, AUSTRALIA, GERMANY and NETHERLANDS.
  • Descripción del producto
    Biphasic LIFEPAK 15 Monitor/Defibrillator. || The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring functions including Non-Invasive Blood Pressure (NIBP). When clinically indicated the LIFEPAK 15 allows the operator to deliver a brief, high energy, external shock through the chest to a patient's heart.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA