Events

Capnostream 20 and Capnostream 20p Bedside Patient Monitors 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
    2018-08-06
  • 사례 출판 날짜
    2018-08-06
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180806.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: medtronic capnostream 20 and capnostream 20p bedside patient monitors medical device manufacturer, medtronic, has issued a medical device safety alert concerning its capnostream 20 and capnostream 20p bedside patient monitors. the manufacturer has received customer reports that the date/time, nurse call and alarm settings of capnostream 20 and capnostream 20p bedside patient monitors may reset to the factory default settings when the monitor is powered off. there have been no reports of patient injury related to this issue. investigation revealed that the cause for the reset to the factory default settings is the accelerated discharge of the internal coin cell battery. user-defined institutional default settings are not lost if the monitor is not powered off, even when the internal coin cell battery is depleted. this issue does not affect the operation of the monitor’s removable li-ion battery or any other aspect of the monitor’s operation. only the reset of user-defined institutional default settings as described are affected. the manufacturer is developing a software update that will ensure user-defined institutional default settings are not lost if the monitor is powered off, except the date/time, regardless of the internal coin cell battery charge level. this software update will be available in october 2018. affected user should download the software update from the manufacturer’s website when it is available. the manufacturer will issue an update to the operator’s manual to note that the date/time setting should be verified at power on. the manufacturer is recommending continued use of capnostream devices. users should confirm that the date/time is accurately displayed. if the date/time requires reset, all user defined settings, such as alarms and nurse call, will also require reset until the software is updated. affected users should follow the instruction in the operator’s manual to set user-defined default settings. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 6 august 2018.

Device

Capnostream 20 and Capnostream 20p Bedside Patient Monitors
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Capnostream 20 and Capnostream 20p Bedside Patient Monitors
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH