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 Radiometer Medical.

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 034 07 13 000
  • Date de mise en oeuvre de l'événement
    2013-07-04
  • 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=5&rid=3882
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Cause
    Radiometer has recently become aware that one lot of membrane boxes has been produced using an incorrect electrolyte solution. some of these membranes have been found to calibrate and provide valid results on the analyzer for a few days (4-6 days), before cal 2 fails on zero point. when this happens the membrane units will have a rapidly increasing positive bias until they are rejected by the following cal 2. cal 2 is run every 4 hours, and within this time slot there is a possible risk of obtaining wrong measuring results.

Device

IVD: Blood gas electrode, oxygen, pO2 membrane units for ABL5/50/500
  • Modèle / numéro de série
    D999 Membrane box for E909 pO2 electrode for ABL5/50/5XX, 942-042, R0971
  • Description du dispositif
    An electrical conducting device used to determine the concentration of oxygen (O2) in a sample of blood
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Représentant du fabricant
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA