Events

Alerte De Sécurité sur Inspira AIR Balloon Dilation System, size 18X40mm

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

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
    2012-03-14
  • 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_20120314b.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
    Field safety notice: acclarent inspira air balloon dilation system, size 18x40mm the food and drug administration (fda), united states, has issued a class i recall concerning inspira air balloon dilation system, size 18x40mm (product code: bc1840a) manufactured by acclarent, inc.. fda reported that there is potential for the balloon to not deflate or to deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient. this product may cause serious adverse health consequences, including death. according to the report, the manufacturer has received four reports of incidents, one resulting in patient injury, in which the device has apparently malfunctioned. in each of these cases, difficulty deflating the balloon occurred after the surgeon pulled against resistance in response to the balloon moving distally during dilation. the force applied to the catheter stretched and narrowed the catheter shaft, causing the balloon to be difficult or impossible to deflate. the manufacturer recommends customers immediately discontinue use of the affected products. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm295488.Htm and http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm295875.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

Inspira AIR Balloon Dilation System, size 18X40mm
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm
  • Manufacturer
    Acclarent

Manufacturer

Acclarent