Events

Alerte De Sécurité sur Disposable paediatric ventilation circuit for Oxylog Transport Ventilators

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Draeger Medical GmbH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-05-26
  • Date de publication de l'événement
    2016-05-26
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160526.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: draeger disposable paediatric ventilation circuit for oxylog transport ventilators medical device manufacturer, draeger medical gmbh, has issued a medical device safety alert concerning its disposable paediatric ventilation circuit ventstar oxylog 3000f (p) 190 [part number: 5704964; date of manufacture: up to 03-2016] for oxylog 3000 and oxylog 3000 plus transport ventilators. during the course of routine internal testing, the manufacturer detected isolated leakages at the check valve (one way valve of the inspiration branch) of the affected device. further detailed investigations have shown that the check valve functions properly with no leak observed at positive end-expiratory pressures above 5 mbar / cmh2o. the problem only occurs at peep values below 5 mbar / cm h2o. according to the manufacturer, leakage at the check valve can result in patient’s exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the exhaled gas with reduced oxygen concentration for the patient. the manufacturer recommends that the users immediately inspect any stock and dispose of any product (part number 5704964) with a date of manufacture up to and including 03-2016. if it is necessary to use affected ventilation circuits prior to receiving replacements, the manufacturer recommends only using the circuit at a peep setting of > 5 mbar / cmh2o, provided that a peep setting of > 5 mbar / cmh2o is appropriate from a medical point of view. additionally, the manufacturer recommends for this use case the use of external co2 monitoring by means of a paediatric cuvette and co2 mainstream sensor. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 may 2016.

Device

Disposable paediatric ventilation circuit for Oxylog Transport Ventilators
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Draeger Disposable paediatric ventilation circuit for Oxylog Transport Ventilators
  • Manufacturer
    Draeger Medical GmbH

Manufacturer

Draeger Medical GmbH