Events

Automatic CPAP device DREAMSTATION 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc || Respironics Medical Products (Shenzhen) Co, Ltd 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
    I1703-116
  • 사례 연번
    2016DM-0014710
  • 날짜
    2017-03-30
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=95
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that it has identified that the medicoreferenced device experienced an erroneous configuration during its manufacture, which prevents the modem from making a satisfactory connection to the internet, a replacement of this modem is required to ensure a successful data transmission.

Device

Automatic CPAP device DREAMSTATION
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The CPAP DREAMSTATION device is an automated system whose indication of use is to provide the patient with a positive depression therapy in the respiratory tract for the treatment of obstructive sleep apnea (OSA) in spontaneously breathing patients weighing more than 30 kg. It can be used both at home and in a hospital or health center. The DREAMSTATIONCPAP pro can also perform CPAP check therapy, and the DREAMSTATION AUTO CPAP can perform CPAP decompression therapy and AUTO CPAP therapy. The ramp function allows you to reduce the pressure when you are trying to stay calm. The air pressure will gradually increase until reaching the prescribed pressure. It comes with accessories and accessories for its total operation.
  • Manufacturer
    Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc || Respironics Medical Products (Shenzhen) Co, Ltd

Manufacturer

Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc |...
  • 제조사 모회사 (2017)
    Philips
  • Source
    NIDFSINVIMA