Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Philips Healthcare.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 098 04 14 000
  • Date de mise en oeuvre de l'événement
    2014-04-16
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=5681
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Risk of battery failure increases with age, when a battery remains in use longer than 3 years after the date of manufacture or 500 charge-discharge cycles. such failure may result in overheating. overheating of the battery may cause the battery to ignite or explode, which may result in injury to a patient or user.

Device

Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors
  • Modèle / numéro de série
    The following IntelliVue Patient Monitors with software releases up to and including G.0(SW B.0/B.1/C.0/D.0/E.0/F.0/G.0) containing battery operation. Model Number MP2, Product Numbers M3002A Model Number X2, Product Numbers M8102A Model Number MP5, Product Numbers M8105A Model Number MP5, Product Numbers M8105AT Model Number MP20, Product Numbers M8001A Model Number MP30, Product Numbers M8002A Model Number MP40, Product Numbers M8003A Model Number MP50, Product Numbers M8004A
  • Description du dispositif
    Monitors, IntelliVue Patient Monitors
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Société-mère du fabricant (2017)
    Philips
  • Représentant du fabricant
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA