Events

Alerte De Sécurité sur intellivue patient monitors and avalon fetal 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
    2014-10-15
  • Date de publication de l'événement
    2014-10-15
  • 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_20141015.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: philips intellivue patient monitors and avalon fetal monitors medical device manufacturer, philips, has issued a field safety notice (fsn) concerning: intellivue patient monitors with software revisions j.21.03 and j.21.19; and model (product) numbers of mp5 (m8105a), mp5sc (m8105as), mp5t (m8105at), and mp5 upgrades (m8105au, 866327) avalon fetal monitors with software revision j.30.58; and model (product) numbers of fm20 (m2702a), fm30 (m2703a) and fm50 (m2705a) in time-synchronized automatic/sequence mode the non-invasive blood pressure (nbp) automatic measurement series is stopped inadvertently, if the repetition interval is increased manually by the user (e.G. from 5 to 15 minutes) in between two consecutive measurements. a prompt message “any ongoing nbp measurement and automatic cycle stopped” is displayed and a single tone sounds when the measurement series is stopped. after the automated measurement series has been stopped, nbp numeric, repetition time, and time to next measurement are no longer displayed, i.E. the nbp numeric field is blank. if the nbp measurement is stopped, and a patient’s blood pressure is not being monitored, a delay in treatment could occur. customers with affected devices will be contacted to arrange a software upgrade to correct the issues. during the interim period until the software is upgraded, users should make sure, if the nbp repetition interval needs to be increased (e.G. from 5 to 15 minutes), to restart the automatic nbp measurement. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 15 october 2014.

Device

intellivue patient monitors and avalon fetal monitors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips IntelliVue Patient Monitors and Avalon Fetal Monitors
  • Manufacturer
    Philips

Manufacturer

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