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 Handicare AB.

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 212 08 15 000
  • Date de mise en oeuvre de l'événement
    2015-08-30
  • 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=8165
  • 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
    Transition gate manual is used to connect two rails in a ceiling lift system. typically it connects a single rail to a traverse system. the design of transition gate manual forces the safety pins in the gate to their upper, open, position when the rails are aligned and ensures that the safety pins are pushed back to their lower, closed, positions when the rails are pulled apart. if the safety pin is pushed repeatedly by one of the trolley types mentioned above, the wiggling of the trolley will cause a movement of the safety pin upwards . this can only occur if transition gate manual is used in combination with the types of trolleys specified above, and with a low load or non-load onto the lift. the friction between the bushing and the safety pin can hinder the pin from falling down by itself, leaving the rail open and allowing the trolley to pass and fall to the floor.

Device

Transition gate manual in combination with Reda ceiling lift unit or trolley HCS5 / HCS37
  • Modèle / numéro de série
    Model: 50400226, 50400237, 50400238 See attached FSN
  • Description du dispositif
    Stationary patient lifting system, line-powered
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB
  • Société-mère du fabricant (2017)
    Handicare Group Ab
  • Représentant du fabricant
    Al Safwa Dimensions
  • Source
    SFDA