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 GE 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 027 11 11 000
  • Date de mise en oeuvre de l'événement
    2011-11-09
  • 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=1001
  • 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
    The carescape monitor b650 may freeze in the middle of the start-up sequence, or enter into a continuous reboot cycle, preventing the normal use of the patient monitor. this may happen during monitor start-up by the operator or during patient monitoring. the carescape monitor b650 may lose audible alarms and qrs beep tone if the monitor is connected to an external information or data collection system via a usb port, and the user disconnects the usb cable from the patient monitor. in this situation, the monitor does not provide any indication that it cannot sound audible alarms. the audible alarms are re-enabled only after the monitor has been manually restarted by the operator.

Device

Electrocardiography, CARESCAPE Monitor
  • Modèle / numéro de série
    Model: B650 V1.1.8 and earlier
  • Description du dispositif
    Monitors, Bedside, Electrocardiography
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare