Events

NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Bedfont Scientific 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
  • 날짜
    2013-12-11
  • 사례 출판 날짜
    2013-12-11
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131211.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: bedfont scientific noxboxi inhaled nitric oxide delivery and monitoring device the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a medical device safety alert concerning noxboxi inhaled nitric oxide delivery and monitoring device , manufactured by bedfont scientific ltd. the affected serial numbers are identified as follows: ni100004, ni100006, ni100009, ni100010, ni100011, ni10012, ni100013, ni100014, ni100015, ni100016, ni100017, ni100018, ni100019, ni100020, ni100022, ni100024, ni100025, ni100027, ni100028, ni100029, ni100030, ni100031, ni100032, ni100034, ni100035, ni100036, ni100037, ni100038, ni100039, ni100040, ni100042, ni100043, ni100044, ni100045, ni100046, ni100047, ni100048, ni100049, ni100050, ni100051, ni100052, ni100053, ni100054, ni100055 ni100056, ni100057, ni100058, ni100059, ni100060, ni100061, ni100062, ni100064, ni100065, ni100066, ni100067, ni100071, ni100072, ni100073, ni100074, ni100075, ni100076, ni100077, ni100079 according to the manufacturer, a fault has been identified within the noxboxi firmware, whereby after 6 days of continuous use the screen may freeze/lock and will not respond. after another unknown period of hours this may cause the system to crash and enter “safe” mode, at this point delivery of nitric oxide (no) therapy is stopped. if the patient is dependent on inhaled nitric oxide, this failure could result in serious injury or death of the patient. the manufacturer advises users not to use the noxboxi continuously for a period longer than 6 days until a firmware upgrade is implemented on the device. a firmware fix has been released to prevent this fault from occurring (0.0.12.1), which users must install on their device immediately. if the device already has this firmware version installed no action is required. for details, please visit the following mhra website:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con341279 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 december 2013.

Device

NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Bedfont Scientific NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device
  • Manufacturer
    Bedfont Scientific

Manufacturer

Bedfont Scientific