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 B Braun Medical Inc..

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 112 09 18 000
  • Date de mise en oeuvre de l'événement
    2018-09-26
  • 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=13222
  • 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
    In the course of post market surveillance activities we discovered that the above specified power cords might get damaged at the device connector. in very rare cases, the device connector might break if heavy lateral force is applied (see figure 1). if exposed electrical contacts are touched the user might be opposed to the potential risk of an electrical shock.

Device

220-240V Unit Cable (power cord) for Infusomat fmS, Infusomat P and SpaceCover
  • Modèle / numéro de série
    Affected power cords have been manufactured by B Braun supplier HAWA in the period from July 2016 (marked as M7 Y6) until June 2018 (marked as M6 Y8). The affected power cord has been shipped together with one of the following products: Infusomat P Deutsch 230 V (8712174), Infusomat P Netherlands 230 V (8712190), Infusomat P Czech 230 V (8712344), Infusomat P English 230 V (8712379), SpaceCover Comfort (8713145), SpaceCover Standard (8713147), Infusomat fmS Deutsch 230 V (8715424), Infusomat fmS Danish 230 V (8715432), Infusomat fmS Spanish 230 V (8715459), Infusomat fmS French 230 V (8715521), Infusomat fmS English 230 V (8715548), Infusomat fmS Italian 230 V (8715564), Infusomat fmS Czech 230 V (8715580) and as separate 220-240V Unit Cable (34502718).
  • Description du dispositif
    Infusion pumps, power cord
  • Manufacturer
    B Braun Medical Inc.

Manufacturer

B Braun Medical Inc.