Events

Alerte De Sécurité sur BCI Remote Alarm Cables

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

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
    2013-04-10
  • Date de publication de l'événement
    2013-04-10
  • 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_20130410.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: smiths medical bci remote alarm cables the united states food and drug administration (fda) has posted a medical device safety alert issued by medical device manufacturer, smiths medical asd, concerning its bci remote alarm cables (no=normally open, nc=normally closed), used with 9004 the capnocheck capnography (plus or sleep) system, reorder numbers: ww3398no & ww3398nc [lot no.: ww3398no0820, ww3398no0847, ww3398no0948, ww3398nc0822, ww3398nc0847, and ww3398nc0947]. these cables were distributed in colorado, illinois, indiana, massachusetts, south carolina, and wisconsin from october, 2008 through september, 2012. the bci remote alarm cables are designed for use with the 9004 capnocheck capnography (plus or sleep) system to transfer alarm signals from the capnocheck capnography system to a remote alarm system. the manufacturer has become aware that, in rare instances, the bci remote alarm cables (bci cables) are not transferring alarms when used with some remote nurse alarm systems. these products may cause serious adverse health consequences, including death. according to fda, the manufacturer has notified its customers by an “urgent medical device field safety notice-recall” letter to instruct customers to inspect their inventory and remove all affected devices from use. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm347193.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 april 2013.

Device

BCI Remote Alarm Cables

Manufacturer

Smiths Medical ASD