Events

Retiro De Equipo (Recall) de Device Recall LIFEPAK CR Plus

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
    34534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0547-06
  • Fecha de inicio del evento
    2006-01-31
  • Fecha de publicación del evento
    2006-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44029
  • 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
    One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
  • Acción
    On 1/31/06 the firm sent a letter flagged URGENT-MEDICAL DEVICE RECALL to their customers via certified return receipt. The letter advised customers of the problem and requested the customers inspect their units at least weekly. The customers are provided additional guidance if they see certain symbols as described in the letter. The firm''s service personnel will visit the customers, remove and replace units.

Device

Device Recall LIFEPAK CR Plus
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA (and Puerto Rico) and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada , Chile, Colombia, Dominica, Germany, Hong Kong, Hungary, Jamaica, Japan, Mexico, Netherlands, New Zealand, Singapore, Uruguay, Venezuela, and Virgin Islands.
  • Descripción del producto
    LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. || LIFEPAK CR Plus AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.
  • 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