Events

Safety Alert for 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],

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    201
  • Date
    2000-11-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The medical devices agency mda issued a safety information 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...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA