Events

Retiro De Equipo (Recall) de Device Recall LIFEPAK 12 Defibrillator/MonitorAC Power Adapter

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
    57563
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1548-2011
  • Fecha de inicio del evento
    2010-10-01
  • Fecha de publicación del evento
    2011-03-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96630
  • 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
    L1fepak 12 operating instructions that describe the process for disconnecting the device from ac (wall) power are not always being followed. when the instructions are not followed and the power on button is pushed within 2 seconds after disconnecting the device from ac power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing.
  • Acción
    Physio Control, Inc. began mailing the URGENT-MEDICAL DEVICE INFORMATION letter to their consignees on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were advised to follow the current LIFEPAK 12 Operating Instructions-Section 7.5-AC Power Adapter Operation and wait at least 2 seconds to push the Power ON button after disconnecting the device from AC power. If the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power and the service indicator illuminates, it's important to be aware that turning the device off, then back on again, will reset the device and restore full functionality. The complete copy of the current LIFEPAK 12 Operating Instructions can be downloaded from the company's website at www.physio-control.com/products/ defibrillators, Select LIFEPAK 12, Select Documents. The consignees can call the firm's Technical Support Team at 1-800-442-1142, option 5, between 6:00 A.M. to 4:00 P.M. (Pacific), Monday - Friday.

Device

Device Recall LIFEPAK 12 Defibrillator/MonitorAC Power Adapter
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.Devices were distributed to the following countries: ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.
  • Descripción del producto
    The LIFEPAK12 Defibrillator/Monitor. || The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a defibrillation shock is needed by looking at the ECG rhythm display. Advisory mode can be useful during monitoring; CPSS (Continuous Patient Surveillance System) runs in the background and alerts the operator when a shockable rhythm is detected.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

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