Events

Alerte De Sécurité sur Heated Ventilator and CPAP Breathing Circuits

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

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
    2012-10-04
  • Date de publication de l'événement
    2012-10-04
  • 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_20121004.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: armstrong medical heated ventilator and cpap breathing circuits the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning heated ventilator and cpap breathing circuits, manufactured by armstrong medical limited. the affected devices could be identified by the following information: catalogue no.: amcp- or amho- or amvc17- or amvc18-. lot no.: 080310 to 310812 (ddmmyy) or expiry date in the range 2015-02 to 2017-07 the manufacturer is investigating a component used in its heated ventilator and cpap breathing circuits manufactured using corrugated tubing. this notice does not apply to any armstrong medical heated breathing circuit manufactured using smooth bore tubing. the component is referred to as a heater wire retainer and is located in the heated limbs of adult (22mmo) corrugated heated ventilator and cpap breathing circuits as a means to locate the heater wire in a fixed position. the retainer is white or off-white in colour and made from polymeric (plastics) material. if breakage of this component were to occur there could be a possible inhalation risk to the patient. 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 4 october 2012.

Device

Heated Ventilator and CPAP Breathing Circuits
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Armstrong Medical Heated Ventilator and CPAP Breathing Circuits
  • Manufacturer
    Armstrong Medical Limited

Manufacturer

Armstrong Medical Limited