GemStar Power Supply 3VDC 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Hospira 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
    2014-11-06
  • 사례 출판 날짜
    2014-11-06
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: hospira gemstar power supply 3vdc the united states food and drug administration (fda) posted a medical device safety alert concerning gemstar power supply, 3vdc, manufactured by hospira.The affected devices are identified as follows: wall mount power supply [list number:13026-05] desk top power supply [list number:13072-05] according to the fda, the power supply may not properly deliver electric power to the gemstar infusion pump. if the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used. the manufacturer received a total of 20 reported incidents including one report of smoke and found that the gemstar infusion pump was operating on battery power while connected to the 3vdc power supply. there were no reports of injuries or death. the manufacturer advises users to take the following precaution: avoid arcing, wiggling, or dropping the power supply on hard surfaces. doing so may result in internal damage that would stop the power supply from working. affected users are advised to remove the power supply from service. according to the manufacturer, there is no need to return fully functional power supplies (unless they malfunction). for details, please refer to the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm421951.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm421946.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2014.

Device

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DH