Events

Alerte De Sécurité sur Electric Reclining Chairs for. CHAIRS, EXAMINATION / TREATMENT [16-437]. Chairs, Disabled Patient [18-406]. Chairs, Disabled Patient, Geriatric [10-796]. Chairs, Disabled Patient, Pediatric [10-797]. Chairs, Disabled Patient, Seat-Lifting [17-975]. Chairs, Examination / Treatment, Dentistry [10-792]. Chairs, Examination / Treatment, Ophthalmology [15-723]. Chairs, Examination / Treatment, Otorhinolaryngology [10-794]. Chairs, Examination / Treatment, Pediatrics [16-169]. Chairs, Examination / Treatment, Podiatry [10-799]. Chairs, Flotation Therapy [10-795]. Chairs, Mammography [18-402]. Chairs, Patient Recovery [18-404]. Chairs, Patient Transfer [16-639]. Chairs, Patient Transfer, Stair [16-906]. Chairs, Radiography / Fluoroscopy [16-673]. Chairs, Radiography / Fluoroscopy, Head [18-400]. Chairs, Radiography / Fluoroscopy, Head / Torso [18-401],

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
    198
  • 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 medical devices agency (mda) has issued a safety bulletin informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
  • Action
    MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.

Device

Electric Reclining Chairs for. CHAIRS, EXAMINATION / TREATMENT [16-437]. Chairs, Disabled Patient...
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA