Alerte De Sécurité sur BARIATRIC REHABILITATION PLATFORM BEDS (BARIATRIC REHABILITATION PLATFORM BEDS

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par WHEELCHAIRS OF KANSAS.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    139
  • Date
    2000-09-29
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    An ecri member hospital reported two incidents in which the accession of the bariatric rehabilitation platform is released, causing injury to the nurse. the course of the launder was still under the nurse that has not being adjusting the equipment that holds handling.
  • Action
    MAKE SURE THAT TEAM MEMBERS ARE TRAINED ABOUT THE CORRECT USE OF THE BED SHEET MECHANISM. REPORT TO EMPLOYEES THAT HANDLING CAN FALL IF IT IS NOT TIGHT WELL. (2) MAKE SURE THAT EMPLOYEES ROTINALLY CHECK THE MECHANISM OF THE LAYOUT OF THE BED TO MAKE SURE THAT THE SAME IS SECURELY ADAPTED / TIGHTENED, AS WELL AS THE OTHER MECHANISMS OF THE BED. (3) ENSURE EMPLOYEES NOT TO DRIVE OR MOVE BRUSHLY AGAINST COURT BURNING TO PREVENT NON-INTENTIONAL LOOSENING. (4) IF THERE ARE ANY SUSPICIOUS PROBLEMS WITH THE BED, PLEASE CONTACT YOUR LOCAL DISTRIBUTOR OR DIRECTLY WITH WHEELCHAIRS OF KANSAS

Manufacturer

  • Source
    ANVSANVISA