Events

Alerte De Sécurité sur atar extension cable

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

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
    2017-07-07
  • Date de publication de l'événement
    2017-07-07
  • 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_20170707.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: atar extension cable the food and drug administration (fda), united states has posted a medical device safety alert concerning atar extension cable, reusable and disposable models, manufactured by oscor. during the use of some atar extension cables, the cable was separating from the connector at the proximal end. the analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use. this event resulted in cable malfunction, causing interruption of the pacing system. according to the manufacturer, they received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries. no deaths were reported; however the risk for possible injury is a concern if the cable separates during use. for pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. continuous monitoring is required. product recall is on-going. for details, please refer to the fda websites: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm566006.Htm https://www.Fda.Gov/safety/recalls/ucm566001.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 july 2017.

Device

atar extension cable
  • Modèle / numéro de série
  • Classification du dispositif
    Physical Medicine Devices
  • Description du dispositif
    Medical Device Safety Alert: ATAR Extension Cable
  • Manufacturer
    Oscor

Manufacturer

Oscor