Events

Alerte De Sécurité sur Grab'n Go Vantage Portable Oxygen Cylinder Unit

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

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
    2013-01-04
  • Date de publication de l'événement
    2013-01-04
  • 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_20130104.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: praxair grab'n go vantage portable oxygen cylinder unit medical device manufacturer, praxair inc. has issued a medical device safety alert concerning grab ‘n go vantage portable oxygen cylinder unit (catalogue no.: ox-m-aegngvntg (us and canada) and wesprx-9500 (global). the manufacturer has initiated a field safety corrective action for the grab'n go vantage portable oxygen cylinder unit because fires may occur inside the cylinder unit causing the wall of the unit to break and release oxygen. the fires are self extinguishing and may be caused by physical impact such as dropping or knocking over the cylinder unit. if a fire occurs, users may experience burns or a lack of oxygen (hypoxia). this product may cause serious adverse health consequences, including death. customers were instructed to send the affected device to the manufacturer for servicing and refilling after use in accordance with their normal processes. for further details, please refer to the fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0525-2013&w=01022013&lang=eng http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm333846.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 04 january 2013.

Device

Grab'n Go Vantage Portable Oxygen Cylinder Unit
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Praxair Grab'n Go Vantage Portable Oxygen Cylinder Unit
  • Manufacturer
    Praxair Inc.

Manufacturer

Praxair Inc.