Events

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], 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    195
  • 날짜
    2000-11-03
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    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.
  • 조치
    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...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA