Retiro De Equipo (Recall) de Device Recall defibrillator/monitor

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
    55875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1722-2011
  • Fecha de inicio del evento
    2010-05-27
  • Fecha de publicación del evento
    2011-03-18
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-09-29
  • 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 MKJ
  • Causa
    A component failure on the ac power supply assembly results in "no ac power" operation. a failure of ac power can result in a delay of defibrillation therapy if backup battery power is depleted.
  • Acción
    PhysioControl, Inc. began sending an Urgent Medical Device Correction letter via certified receipt to all affected customers describing the potential issue. Customers were advised to keep the defibrillators in service and to follow the daily Operator's Checklist. All power supplies will be updated. For questions customers were instructed to contact Technical Support at 1-800-442-1142. For questions regarding this recall call 425-867-4000.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MI, MD, MI, NC, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY and the coutnries of ANGUILLA, ARGENTINA, AUSTRALIA, BAHAMAS, BAHRAIN, BARBADOS, BOLIVIA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, GERMANY, GUAM, GUATEMALA, HONG KONG, INDIA, IRAN, ISRAEL, JAMAICA, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PUERTO RICO, SAUDI ARABIA, SOUTH AFRICA, SYRIA, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIRGIN ISLANDS, and YEMEN.
  • Descripción del producto
    The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000. || The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e are acute cardiac care devices used by authorized healthcare providers in hospital and clinic settings. It is commonly found on "code" or "crash" cars in hospital hallways, plugged into AC power. In an emergency the user retrieves the cart, unplugging the monitor, and uses the device with the door closed for easy 1-2-3 operation. When the code team arrives the user will open the door and have access to all functions, including ECG monitoring. In addition to functioning as a semi-automatic defibrillator the LIFEPAK 20/20e provides options for: ECG monitoring, manual mode defibrillation; Non-invasive pacing; synchronized cardioversion; pulse oximetry (SpO2); hard paddles (adult and pediatric) and internal paddle accessories; printing; and backup batter power. The units are biphasic waveform devices
  • Manufacturer

Manufacturer

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