Events

Alerte De Sécurité sur PARI SOLE N Inhalation Device

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

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
    2012-09-11
  • Date de publication de l'événement
    2012-09-11
  • 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_20120911c.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: power adapter used in pari sole n inhalation device the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning the power adapter manufactured by friwo used in pari sole n inhalation device. pari gmbh has received a small number of complaints regarding the mains adapter manufactured by friwo that is used with the pari sole n inhalation device. the complaints received concerned the mains adapter overheating and causing a certain part of the power adapter housing to melt. it may pose the risk of electric shock or fire. none of the reported incidents led to any personal injury or damage due to fire. the manufacturer advised users to inspect the power adapter before each use to ensure that it is not damaged. the device must not be switched on if damaged or damage is suspected. users should contact the manufacturer for replacement of the power adapter. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/ safetywarningsalertsandrecalls/fieldsafetynotices/con184398 if you are in possession of the product, please contact your supplier for necessary actions. posted on 11 september 2012.

Device

PARI SOLE N Inhalation Device
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Power Adapter used in PARI SOLE N Inhalation Device
  • Manufacturer
    FRIWO

Manufacturer

FRIWO