Events

Alerte De Sécurité sur Product name: Patient Monitor Intellivue Technical Name: Vital Signs Monitor ANVISA Registration Number: 10216710215 Hazard Class: III Affected Model: MX400, MX400, MX500, MX500, MX700, MX800 Affected serial numbers: DE44307469, DE44307475, DE33105118, DE33105135, DE33105136, DE33105139, DE33105149, DE33105151, DE33105152, DE33105153, DE33105154.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Philips Medical Systems Ltda.; Philips Medizin Systeme Böblingen GmbH..

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
  • ID de l'événement
    2301
  • Date
    2017-05-25
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Immediately identify all affected cables, remove them from stock, and save them for exchange by a Philips Health Care Authorized Service Provider. Review this information with all members of your team who need to be aware of the content of this communication. It is important to understand the content of this communication.
  • Cause
    A small number of intellivue patient nmt cables may contain an insulation defect located in the throttle sensor housing shield. this manufacturing defect can cause localized heating due to unintentional current flow between the housing of the acceleration sensor attached to the thumb and the nmt stimulation electrode attachment attached to the hand pulse of the same hand.
  • Action
    Field Action Code FCO86201777 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will fix the equipment in stock.

Device

Product name: Patient Monitor Intellivue Technical Name: Vital Signs Monitor ANVISA Registration ...

Manufacturer

Philips Medical Systems Ltda.; Philips Medizin Systeme Böblingen GmbH.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA