Events

Alerte De Sécurité sur SenSit Chair

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

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
    2013-07-02
  • Date de publication de l'événement
    2013-07-02
  • 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_20130702.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: protac sensit chair the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning the following sensit chair manufactured by protac a/s: product no.: 600-601 standard model product no.: 600-701 high model product no.: 600-601-3500 standard model product no.: 600-701-3500 high model protac has heard that an over-excited child in the uk managed to get his head caught in one of the carrying straps on the protac sensit chair. as the strap sat around the child’s throat, he was unable to free himself. however, the staff managed to cut the handle so that fortunately nothing happened to the child. to minimize events of this type from recurring, the manufacturer has implemented the following measures: protac is sending a safety notice together with a warning (please note! take care to ensure the user’s head does not get caught in the carry straps.) to institutions and private customers who have purchased or who are using protac sensit chairs to draw their attention to this potential risk. protac is also sending the safety notice with the warning to all foreign dealers in europe and australia, who must in turn inform their customers, institutions and private customers of this potential risk. protac has redesigned the carrying straps on its protac sensit chair so that the new chair has new and safe straps. protac advises the customers to assess the safety risk and implement any precautionary measures whenever necessary. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con286973 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 july 2013.

Device

SenSit Chair
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Protac SenSit Chair
  • Manufacturer
    Protac A/S

Manufacturer

Protac A/S