Events

Alerte De Sécurité sur IntelliSpace Critical Care & Anesthesia Clinical Information System

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 Healthcare.

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
    2014-11-28
  • Date de publication de l'événement
    2014-11-28
  • 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_20141128.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 healthcare intellispace critical care & anesthesia clinical information system medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its intellispace critical care & anesthesia clinical information system. the affected devices are identified as follows:- 865047 intellivue clinical information portfolio (icip), rev d 865209 intellivue clinical information portfolio (icip), rev e 866072 intellispace critical care & anesthesia (icca), rev. f 866148 intellispace critical care & anesthesia (icca), rev. g according to the manufacturer, a software configuration defect has been identified that impacts one standard content (configuration that is shipped with the product) unit of measure (gm/m2). the defect involves an incorrect multiplier in the configuration that causes an incorrect calculation of medication dosage. the error could result in a calculated dose that is 10 times the correct dose. if the user does not identify that an incorrect multiplier exists in the standard content, a patient may receive a dose of medication that is incorrect (10 times the intended dosage). users are advised to implement the instructions outlined in the mandatory field change order (fco) if the body surface area (bsa) (gm/m2) standard content is used in the configuration. the manufacturer has initiated a correction to address this issue and a manufacturer’s representative will contact users to schedule the implementation of this correction. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 november 2014.

Device

IntelliSpace Critical Care & Anesthesia Clinical Information System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Healthcare IntelliSpace Critical Care & Anesthesia Clinical Information System
  • Manufacturer
    Philips Healthcare

Manufacturer

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