Events

Alerte De Sécurité sur OxyTOTE Valve Integrated Pressure Regulators

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

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
    2015-02-02
  • Date de publication de l'événement
    2015-02-02
  • 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_20150202.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: western / scott fetzer co. oxytote valve integrated pressure regulators health canada posted a medical device safety alert concerning oxytote valve integrated pressure regulators (viprs) [model numbers: mnr-600, mns-603, mtr-500, mtr-700, mts-501, mts-502, mts-503], manufactured by western / scott fetzer co. the manufacturer decided to initiate this recall based on reports of ignition events involving oxytote valve integrated pressure regulators (viprs) and the subsequent investigations into those events. based on the investigations, the manufacturer has become aware of the possibility of ignition and rupture (i.E., explosion) of the compressed gas oxygen cylinder, which can cause serious injury and/or death. for details, please refer to the following health canada website: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2015/43563r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 february 2015.

Device

OxyTOTE Valve Integrated Pressure Regulators
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Western / Scott Fetzer Co. OxyTOTE Valve Integrated Pressure Regulators
  • Manufacturer
    Western / Scott Fetzer Co

Manufacturer

Western / Scott Fetzer Co