Events

Rappel de MICROSTREAM FILTERLINE ICU

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Healthcare Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58471
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2248-2011
  • Date de mise en oeuvre de l'événement
    2011-04-07
  • Date de publication de l'événement
    2011-05-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99462
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Cause
    Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.
  • Action
    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
  • Modèle / numéro de série
    Manufactured from October 2010 through February 2011. Product Number: 989803159581; Lot Code: M8409P10
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    Philips Microstream¿ Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN 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.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA