Events

Alerte De Sécurité sur RECLINABLE ELECTRIC CHAIRS

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 N/A.

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
    175
  • Date
    2000-11-03
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    The united kingdom medical devices agency has delivered a safety information informing hospitals that there is the risk of children become prematured and machined in the mechanism of reclining electric chairs.
  • Action
    MDA DECLARES THAT ALL PERSONNEL INVOLVED IN THE SUPPLY OF CHAIRS SHOULD ALERT USERS AND ATTENDEES ABOUT THE POTENTIAL RISK OF A CHILD ABUSE AND MACHINING. MDA RECOMMENDS THE FOLLOWING: (1) FOLLOW THE MANUFACTURER'S INSTRUCTIONS (2) MAKE SURE THE CHILDREN ARE SUPERVISED WHEN THEY ARE CLOSE TO THE ABOVE CHAIRS. (3) NEVER ALLOW CHILDREN TO PLAY WITH THE CHAIRS OR THE CONTROLS (4) DISCONNECT THE OUTLET OR REMOVE THE KEY, IF ANY, WHEN THE CHAIR IS NOT IN USE. (5) REPORTING VISITORS AND CHILDREN ON THE POTENTIAL RISK OF AGGRESSES. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL SUPPLIER REPRESENTATIVE OR DIRECTLY WITH RAY HODGKINSON OR SARAH LEPAK AT THE BRITISH HEALTHCARE TRADES ASSOCIATION BY PHONE 44 (173) 245 8868. CONSULTATIONS TO MDA MUST MENTION REFERENCE NUMBER 20000605.011-22 E BE ADDRESSED TO MALCOLM ROE OR RICHARD GLOVER BY CORRESPONDENCE SUBMITTED TO HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND; BY PHONE (0207) 972 8164 OR 8245; OR BY FAX (0207) 972 8106

Device

RECLINABLE ELECTRIC CHAIRS
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA