Events

Alerte De Sécurité sur practix33plus

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

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
    2012-10-03
  • Date de publication de l'événement
    2012-10-03
  • 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_20121003b.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: philips practix33plus the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning practix33plus, manufactured by philips medical systems. from recent evaluations, the manufacturer have identified a potential issue in practix33plus that the welding seam of the tube support arm assembly might be imperfect, leading to a potential risk for a collapsing support arm. there is a potential for a serious injury of persons in case the support arm falls down on a patient's body. the manufacturer requested the customer to check the system for the safety flange. when there is no "safety flange" installed, the device is potentially at risk. when this flange exists the product is safe. in case there is no flange installed, the welding seams of the arm should be thoroughly checked for possible cracks by an experienced technician. in case of any cracks, immediately stop further operation of the system. philips will install the safety flange at all systems involved. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185586 as a voluntary, precautionary measure and in advance of full details of an incident being made available, the manufacturer has decided to recall potentially affected breathing circuits and replace these with circuits which use an alternative form of retainer made from metal. as a precaution until affected stock can be replaced, users are advised to confirm the absence of loose fragments of heater wire retainer inside the heated limb(s), referring to figure 1 of the field safety notice for guidance. for details, please refer to the mhra website as below: http://www.Mhra.Gov.Uk/safetyinformation/ safetywarningsalertsandrecalls/fieldsafetynotices/con185586 if you are in possession of the products, please contact your supplier for information and necessary actions. posted on 3 october 2012.

Device

practix33plus
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Practix33plus
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH