Events

AED 10 and MRL Jumpstart 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Welch Allyn Protocol, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    51923
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1656-2009
  • 사례 시작날짜
    2009-04-24
  • 사례 출판 날짜
    2009-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81651
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    automated external defibrillator - Product Code MKJ
  • 원인
    Possible for users to misunderstand signals. the original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. if a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to.
  • 조치
    The firm has developed expanded labeling for users and will revise the user manuals for software versins 2.03, 2.04, 2.05, and 2.06. Customers receiving the updated manuals will be sent a cover letter directing them to discard the original user manual and replace it with the updated manual. The April 24, 2009, cover letter will highlight the clarification of directions for use regarding what to do when a low battery indicator is displayed.

Device

AED 10 and MRL Jumpstart
  • 모델명 / 제조번호(시리얼번호)
    software versions 2.03, 2.04, 2.05, and 2.06
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Guam, Puerto Rico, Canada, Mexico, Andorra, UAE, Afghanistan, Australia, Azerbaijan, Belgium, Belarus, Bermuda, Bahrain, Brazil, British West Indies, Switzerland, China, Cyprus, Czech Republic, Germany, Denmark, Algeria, Egypt, Spain, France, French Guiana, French Lesser Antilles, Greece, Haiti, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Kenya, Kyrgyz, Lebanon, Lithuania, Luxembourg, Latvia, Monaco, Malaysia, Netherlands, New Zealand, Phillipines, Pakistan, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, United Kingdom, Uraguay, Yemen, and South America.
  • 제품 설명
    Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • 제조사 주소
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA