Events

OXIMAX N-65 PORTABLE PULSE OXIMETER - Registration 10349000315 - Risk Class III (High Risk) - Reference: N65 and N65-1 (Distribution Map in ANNEX) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Auto Suture do Brasil Ltda.; COVIDIEN IIC 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
    1663
  • 날짜
    2015-08-20
  • 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
    SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN65
  • 원인
    Nellcor ™ oximax® n-65 portable pulse oximeters and oximax® n-560 portable pulse oximeters are not showing complete segments of numerical data (see letter to customer), which can lead the end user to misinterpretation of the numerical data. according to emrpesa, the oximetry measurement was not affected, and the problem presented relates solely and exclusively to the numerical demonstration of the display. - letter to clients in annex.
  • 조치
    SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN65

Device

OXIMAX N-65 PORTABLE PULSE OXIMETER - Registration 10349000315 - Risk Class III (High Risk) - Ref...

Manufacturer

Auto Suture do Brasil Ltda.; COVIDIEN IIC
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA