Events

Alerte De Sécurité sur IntelliVue patient monitors

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.

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
    2012-02-14
  • 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_20120214b.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: philips intellivue patient monitors the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning philips intellivue patient monitors. philips has recently received reports that, under certain circumstances, alarms announced at the patient monitor are not announced (either visual or audible) at the central station. only the below referenced models with sw revision h (up to and including h.15.36) are affected. mp20 (m8001a), mp30 (m8002a), mp40 (m8003a), mp50 (m8004a), mp60 (m8005a), mp70 (m8007a), mp80 (m8008a), mp90 (m8010a), intelligent display d80 (m8016a), mx600 (865242), mx700 (865241) and mx800 (865240) if a patient develops a condition leading to an alarm and is being monitored with a monitor which has entered the state where alarm information is not communicated to the central station, clinical personnel monitoring the central station may not be advised of an alarm condition. this could cause a delayed response to the alarm condition of the patient. philips will conduct software upgrade to the affected devices. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

IntelliVue patient monitors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips IntelliVue patient monitors
  • Manufacturer
    Philips

Manufacturer

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