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 033 11 18 000
  • Date de mise en oeuvre de l'événement
    2018-11-12
  • 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=13476
  • 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
    Certain mrx m3538a lithium-ion batteries may contain a defective component should the component fail, the battery will no longer charge or deliver power to the mrx monitor/defibrillator, which may prevent operation of the device if a second charged battery is not installed or if the device is not connected to ac or dc power. additionally, the led status indicator on the battery will not illuminate, even if the battery has a charge. should a second, unaffected battery be present in the heart5tart mrx, the battery failure may go unnoticed.

Device

Philips HeartStart MRx M3538A
  • Modèle / numéro de série
    Product: M3538A Lithium-Ion Batteries for the HeartStart MRx Monitor/Defibrillator Units Affected subject to thi5 Recall: A total of 1,880 Lithium-Ion Batteries manufactured between January 1gth, 2018 and March 20th, 2018 with serial numbers 17362-0001-P through 18057-0266-P
  • Description du dispositif
    Patient Monitoring
  • Manufacturer
    Philips Healthcare

Manufacturer

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