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 Heinen & Loewenstein.

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 143 09 12 000
  • Date de mise en oeuvre de l'événement
    2012-09-19
  • 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=2398
  • 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
    During the uninterrupted operation of the leoni plus for more than 49 consecutive days the device may start a highest priority alarm that results in a continuous alarm sound and a visual alarm on the monitor. as a consequence of this the ventilation will be interrupted preventing potential hazards for the patient. this situation is just a potential scenario that may appear in rare cases where the devices are continuously operated and put into the standby mode during periods not being connected to the patient but never shut down completely during a period of 49 days.

Device

Ventilator, neonatal/paediatric, Leoni plus
  • Modèle / numéro de série
    Serial no.: 0217001xxx, 0217004xxx; Software Version 1.x.x and 2.2.x.;
  • Description du dispositif
    Ventilator, neonatal/paediatric
  • Manufacturer
    Heinen & Loewenstein

Manufacturer

Heinen & Loewenstein
  • Société-mère du fabricant (2017)
    Löwenstein Familien-Stiftung
  • Représentant du fabricant
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA