INTELLIVUE PATIENT MONITOR - Register - 10216710124. INTELLIVUE PATIENT MONITOR, PHILIPS BRAND - Register - 10216710135. INTELLIVUE PATIENT MONITOR, PHILIPS BRAND - Register - 10216710143. INTELLIVUE PATIENT MONITOR, PHILIPS BRAND - Register - 10216710160. INTELLIVUE PATIENT MONITOR - MP80 (M8002A), MP80 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), D80 , MX600 (865242), MX700 (865241), MX800 (865240). LOTS AFFECTED - See annex attachment. http://en.wikipedia.org/w/index.php/ 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 PHILIPS MEDICAL SYSTEMS LTDA. 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
    1119
  • 날짜
    2012-03-14
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    If a patient develops a condition that leads to an alarm and is being monitored with a monitor that has entered a state where the alarm information is not being communicated to the central station, the clinical staff monitoring the central station may not be advised of an alarm condition. This may cause a delayed response to the patient's alarm condition. If you need any further information or support regarding this problem, please contact your local Philips representative. If you need additional information or support regarding this issue, please contact the Solution Center at 0800-701-7789. Customer Service to Fri. from 7:30 a.m. to 7 p.m. and on Saturdays from 8:00 a.m. to 3:00 p.m. There are no records of notifications related to this problem in the NOTIVISA System so far. Anvisa is following this field action.
  • 원인
    Under certain circumstances, alarms triggered on the patient monitor are not triggered (either visual or audible) at the central station. if this problem occurs, the primary alarm function of the monitor next to the bed is not affected. all physiological information transferred from the monitor to the side of the bed will be displayed correctly at the central station.
  • 조치
    Identify the existence of the equipment in your service. Immediately notify the supplier. Philips will provide a software update for all affected devices at no cost. A Philips Healthcare representative will contact customers to arrange an upgrade of the Intellivue software. Until the software update is installed, do not rely on the central station's alarm function. Review this information with all team members who interact with the central station and need to be aware of the contents of this release.

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    ANVSANVISA