detachable power plugs of three models of Medela breast pump 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medela Inc. 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
    2016-09-28
  • 사례 출판 날짜
    2016-09-28
  • 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.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medela uk (type g) detachable power plugs of three models of medela breast pump medical device manufacturer, medela inc., has issued a medical device safety alert concerning its uk (type g) detachable power plugs of three models of medela breast pump. [model (product numbers): 1) swing maxi (200.4726, 040.0005, 040.0007, 040.0010, 040.0014, 040.0015, 040.0016, 040.0019, 040.0024; 2) freestyle (042.0009, 042.0011, 042.0013, 042.0013 01, 042.0015, 099.0272, 099.0274); 3) swing (200.4730, 030.0030, 030.0032, 030.0035, 030.0039, 030.0039 01, 030.0043, 030.0044, 030.0048, 030.0052, 030.0056, 030.0057, 099.0017)]. the manufacturer is launching a voluntary replacement program for uk (type g) detachable power plugs. the detachable plug connects to a power supply base which is included in a breast pump system. since june 2012, the manufacturer has marketed both breast pump systems and replacement power supplies (with enclosed plug adapters). the medela breast pumps with affected detachable power plugs are swing maxi, swing and freestyle. this voluntary replacement program only applies to detachable power plugs for uk sockets. other products or power supply adapters for other sockets are not affected by this voluntary replacement program. also, medela breast pumps themselves, swing maxi, swing and freestyle are not affected. according to the manufacturer, this replacement program is in response to a report where a detachable power plug allegedly broke apart and the respective user experienced an electric shock. if users apply a certain level of force while removing affected detachable power plugs from uk sockets, the detachable power plugs might break apart potentially exposing live parts. as a precautionary measure, the manufacturer asks customers to comply with the following: while removing an affected power supply adapter for uk sockets, remove the plug slowly and deliberately, apply as little force as possible, and handle the whole adapter with utmost attention and caution. if users apply a certain level of force, an affected detachable power plug might break apart. if the detachable power plug breaks, turn off the power source before removing it from the wall. remove the detachable power plug from the power socket and do not use it before a replacement is available. users may use the breast pumps swing and swing maxi with batteries instead of the affected power supply adapter. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the manufacturer’s website: https://www.Medela.Com/breastfeeding/products/important-safety-notice if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 september 2016.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medela UK (Type G) detachable power plugs of three models of Medela breast pump
  • Manufacturer

Manufacturer