Events

Retiro De Equipo (Recall) de MICROSTREAM FILTERLINE ICU

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 Philips Healthcare 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
    58471
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2247-2011
  • Fecha de inicio del evento
    2011-04-07
  • Fecha de publicación del evento
    2011-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99419
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Causa
    Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.
  • Acción
    The firm, Philips, sent a Field Safety Notice titled "URGENT MEDICAL DEVICE RECALL" letter dated April 2011 to its customers. Customer notifications outside the US will be managed by Philips representatives in each affected geography. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all products from affected lots; remove from inventory and dispose in accordance with local regulations (new products will be sent proactively to each affected customer). Direct accounts were instructed to notify additional customers to whom the product has been distributed. These customers are instructed to follow the instructions in the "Action to be taken by Customer/User" section of the Notice. Questions regarding the recall can be directed towards the customer's local Philips representative at 1-800-722-9377.

Device

MICROSTREAM FILTERLINE ICU
  • Modelo / Serial
    Manufactured from October 2010 through February 2011. Product Number: M1923A; Lot Codes: M8330M10 M8386N10 M8411P10 M8451P10 M8477A11 M8514A11 M8572B11  The M1923A Filterline H Set is also shipped as part of the M3015A Measurement Server Extension, Product Option #K33.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    Philips Microstream¿ Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS || These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA