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 Ergolet A/S.

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 081 04 12 000
  • Date de mise en oeuvre de l'événement
    2012-04-21
  • 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=1712
  • 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
    Due to an incident and several claims regarding broken gas springs on the hera ii, and after specific risk analysis, ergolet has decided that replacement of the gas spring is necessary. the back fixture of the gas spring has been known to break after a significant time of use, resulting in the chair to tilt backwards. if a patient is seated in the chair during this malfunction, there is a risk of the patient hurting the back of the head or getting injured in the neck by the sudden backwards movement.

Device

Bathing & Toileting chair, Ergolet Hera II
  • Modèle / numéro de série
    Model number: 041-00250, 041-00255, 041-00256, 041-00280, 041-00281; S/N: 1379 to 2180
  • Description du dispositif
    Bathing & Toileting chair
  • Manufacturer
    Ergolet A/S

Manufacturer

Ergolet A/S