Events

automated external defibrillator LIFEPAK 1000 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Physio-Control 에 의해 제조된 제품과 관련되어 있습니다.

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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
    2017-01-20
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    http://www.info.gov.hk/gia/general/201701/20/P2017012001021.htm?fontSize=1
  • 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
    Press release
  • 원인
     
    safety alert on automated external defibrillator lifepak 1000
    *************************************************************
         the department of health (dh) today (january 20) drew the public's attention to a safety alert concerning the lifepak 1000 defibrillator manufactured by physio-control as this automated external defibrillator would reportedly shut down unexpectedly during patient treatment.

         the dh, through its routine surveillance on medical device safety alerts, noticed the above alert issued by the food and drug administration of the united states.
     
         according to the alert, the manufacturer has received 34 reports that the device has shut down unexpectedly during patient treatment due to an intermittent connection between the battery and device electrical contacts.

         according to the manufacturer, this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this condition can occur over time in lifepak 1000 devices that are exposed to vibration and have a battery installed for a long period of time.

         the alert has indicated that a defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. the manufacturer is aware of eight adverse events related to this issue.

         this issue can potentially affect any lifepak 1000 device. however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the lifepak 1000 defibrillator operating instructions, are more susceptible.

         the dh's enquiries with the manufacturer’s branch office in singapore revealed that 653 units of the potentially-affected device had been distributed in hong kong, including local distributors, medical organisations, estate management agencies, recreational clubs, schools and other venues. 

         "so far, the dh has not received any reports of adverse incidents related to the affected device in hong kong," a spokesman for the dh said.

         "the dh has also informed public and private hospitals and relevant medical associations about the alert and will continue to liaise with the manufacturer on the follow-up actions," the spokesman said.

         members of the public who are in possession of the affected device are advised to immediately remove and reinstall the battery from their devices and to implement a weekly schedule of battery removal and reinstallation for all lifepak 1000 devices. this action will clean the contacts of oxidation and will prevent the issue from occurring.

         according to the manufacturer, if the device powers off unexpectedly, either during inspection or during patient treatment, the battery should be immediately removed and reinstalled to restore power to the device. if the power is not restored, replace the battery with a spare battery and contact the supplier to arrange for servicing of the device.
     
    ends/friday, january 20, 2017
    issued at hkt 20:00
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Device

automated external defibrillator LIFEPAK 1000
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Safety alert on automated external defibrillator LIFEPAK 1000
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DH