Events

Retiro De Equipo (Recall) de Welch Allyn PIC 50 Portable Intensive Care System

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 Welch Allyn Protocol, 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
    56804
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0937-2011
  • Fecha de inicio del evento
    2010-09-17
  • Fecha de publicación del evento
    2011-01-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94552
  • 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
    External Transcutaneous Cardiac Pacemaker (Non-Invasive) - Product Code DRO
  • Causa
    Potential likelihood that the portable intensive care (pic) 50 defibrillator's screen display may fail. the loss of the ability to view the patient's electrocardiogram (ecg) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient.
  • Acción
    On 9/17/10, Welch Allyn began sending out the Important Product Alert letter to all their direct consignees. On 9/24/2010, the firm sent out the letters to their distributors. The Product Alert letter informs the consignees of a low potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The consignees are advised to follow the instruction in the PIC 50 user's manual requiring routine shift equipment checks daily or at each shift change to minimize the likelihood of the malfunction from occurring. The checks ensure that the PIC 50 and its component (including the screen display) are fully operation and undamaged. The letter further states "our analysis indicates that routinely doing such checks will likely lead to discovery of this malfunction as it occurs, and thus timely maintenance and repair". The distributors are advised to communicate this Product Alert to their customers if the devices were further distributed. For customers in US and Canada, distributors are advised to provide the electronic Excel file with customer's name, address, serial number and part number to WA2221@Stericycle.com. For customers in other countries, they are advised to provide information to PIC50Product Alert@welchallyn.com Consignees can call Welch Allyn at 800-289-2500 for any questions during normal business hours.

Device

Welch Allyn PIC 50 Portable Intensive Care System
  • Modelo / Serial
    Devices are identified with Serial Numbers:  1005, 1011, 1012, 1013, 1014, 2355, 80001, 80003, 80007, 80008, 80009, 80012, 80013, 80018, 80022, 80025, 80031, 80032, 80033, 80035, 80042, 80045, 80050, 80059, 80076, 80085, 80117, 80228, 80276, 80281, 80282, 80283, 80285, 80286, 80288, 80289, 80290, 80296, 80297, 80298, 80299, 80301, 80314, 80315, 80316, 80317, 80318, 80319, 80347, 80348, 80349, 80350, 80351, 80352, 80353, 80354, 80355, 80356, 80357, 80358, 80359, 80360, 80361, 80362, 80363, 80364, 80365, 80366, 80367, 80368, 80369, 80370, 80371, 80372, 80373, 80374, 80375, 80376, 80378, 80379, 80380, 80381, 80383, 80384, 80385, 80386, 80387, 80388, 80389, 80390, 80391, 80392, 80393, 80394, 80395, 80405, 80406, 80407, 80408, 80419, 80420, 80423, 80424, 80425, 80426, 80427, 80428, 80429, 80430, 80431, 80432, 80433, 80434, 80435, 80436, 80437, 80438, 80439, 80440, 80441, 80443, 80444, 80445, 80446, 80447, 80448, 80449, 80450, 80451, 80453, 80454, 80455, 80456, 80458, 80459, 80460, 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92594, 92595, 92596, 92597, 92598, 92599, 92600, 92601, 92602, 92603, 92604, 92605, 92606, 92607, 92608, 92658, 92659, 92659, 92660, 92662, 92663, 92667, 92668, 92669, 92670, 92671, NF160001, NF160001, NF160002, NF160002, NF160003, NF160003, NF160004, NF160004, NF160005, NF160005, NF160006, NF160006, NF160007, NF160007, NF160008, NF160008, NF160009, NF160009, NF160010, NF160010, NF160011, NF160011, NF160012, NF160013, NF160014, NF160015, NF160016, NF160017, NF160018, NF160019, NF160020, NF160021, NF160022, NF160023, NF160024, NF160025, NF160026, NF160027, NF160028, NF160029, NF160030, NF160031, NF160032, NF160033, NF160034, NF160035, NF160036, NF160037, NF160038, NF160039, NF160040, NF160041, NF160042, NF160043, NF160044, NF160045, NF160046, NF160047, NF160048, NF160049, NF160050, NF160051, NF160053, NF160054, NF160055, NF160056, NF160057, NF160058, NF160059, NF160060, NF160061, NF160062, NF160063, NF160064, NF160065, NF160066, NF160067, NF160068, NF160069, NF160070, NF160071, NF160072, NF160073, NF160074, NF160075, NF160076, NF160077, NF160078, NF160079, NF160080, NF160081, NF160082, NF160083, NF160084, NF160085, NF160086, NF160087, NF160088, NF160089, NF160090, NF160091, NF160092, NF160093, NF160094, NF160095, NF160096, NF160097, NF160098, NF160099, NF160100, NF160101, NF160102, NF160103, NF160104, NF160105, NF160106, NF160107, NF160108, NF160109, NF160110, NF160111, NF160112, NF160113, NF160114, NF160115, NF160116, NF160117, NF160118, NF160119, NF160120, NF160121, NF160122, NF160123, NF160124, NF160125, NF160126, NF160127, NF160128, NF160129, NF160130, NF160131, NF160132, NF160133, NF160134, NF160135, NF160136, NF160137, NF160138, NF160139, NF160140, NF160141, NF160142, NF160143, NF160144, NF160145, NF160146, NF160147, NF160148, NF160149, NF160150, NF160151, NF160152, NF160153, NF160154, NF160155, NF160156, NF160157, NF160158, NF160159, NF160160, NF160161, NF160162, NF160163, NF160164, NF160165, NF160166, NF160167, NF160168, NF160169, NF160170, NF160171, NF160172, NF160173, NF160174, NF160175, NF160176, NF160177, NF160178, NF160179, NF160180, NF160181, NF160182, NF160183, NF160184, NF160185, NF160186, NF160187, NF160188, NF160189, NF160190, NF160191, NF160192, NF160193, NF160194, NF160195, NF160196, NF160197, NF160198, NF160199, NF160200, NF160201, NF160202, NF160203, NF160204, NF160205, NF160206, NF160207, NF160208, NF160209, NF160210, NF160211, NF160212, NF160213, NF160214, NF160215, NF160216, NF160217, NF160218, NF160219, NF160220, NF160221, NF160222, NF160223, NF160224, NF160225, NF160226, NF160227, NF160228, NF160229, NF160230. NF160231, NF160232, NF160233, NF160234, NF160235, NF160236, NF160237, NF160238, NF160239, NF160240, NF160241, NF160242, NF160243, NF160244, NF160245, NF160246, NF160247, NF160248, NF160249, NF160250, NF160251, NF160252, NF160253, NF160254, NF160255, NF160256, NF160257, NF160258, NF160259, NF160260, NF160261, NF160262, NF160263, NF160264, NF160265, NF160266, NF160267, NF160268, NF160269, NF160270, NF160271, NF160272, NF160273, NF160274, NF160275, NF160276, NF160277, NF160278, NF160279, NF160280, NF160281, NF160282, NF160283, NF160284, NF160285, NF160286, NF160287, NF160288, NF160289, NF160290, NF160291, NF160292, NF160293, NF160294, NF160295, NF160296, NF160297, NF160298, NF160299, NF160300, NF160301, NF160302, NF160303, NF160304, NF160305, NF160306, NF160307, NF160308, NF160309, NF160310, NF160311, NF160312, NF160313, NF160314, NF160315, NF160316, NF160317, NF160318, NF160319, NF160320, NF160321, NF160322, NF160323, NF160324, NF160325, NF160326, NF160327, NF160328, NF160329, NF160330, NF160331, NF160332, NF160333, NF160334, NF160335, NF160336, NF160337, NF160338, NF160339, NF160340, NF160341, NF160342, NF160343, NF160344, NF160345, NF160346, NF160347, NF160348, NF160349, NF160350, NF160351, NF160352, NF160353, NF160354, NF160355, NF160356, NF160357, NF160358, NF160359, NF160360, NF160361, NF160362, NF160363, NF160364, NF160365, NF160366, NF160367, NF160368, NF160369, NF160370, NF160371, NF160372, NF160373, NF160374, NF160375, NF160376, NF160379, NF160380, NF160381, NF160382, NF160383, NF160384, NF160385, NF160386, NF160387, NF160388, NF160389, NF160390, NF160391, NF160392, NF160393, NF160394, NF160395, NF160396, NF160397, NF160400, NF160401, NF160402, NF160403, NF160404, NF160405, NF160406, NF160407, NF160408, NF160409, NF160410, NF160411, NF160412, NF160413, NF160414, NF160415, NF160416, NF160417, NF160418, NF160419, NF160420, NF160421, NF160422, NF160423, NF160424, NF160425, NF160426, NF160427, NF160428, NF160429, NF160430, NF160431, NF160432, NF160433, NF160434, and P1011.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, including states: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and countries of Australia, Austria, Belgium, Canada, China, Columbia, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Mexico, Oman, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and Yemen.
  • Descripción del producto
    Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. || Designed for use in and out of the hospital.
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Dirección del fabricante
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA