Events

Mutiple Laerdal Suction Units (LSU) with NiMH Battery 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Laerdal Pty Ltd 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
    RC-2016-RN-00973-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00973-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Laerdal medical has become aware of a problem related to the use of the laerdal suction unit (lsu) when used with the lsu nimh battery that has been stored or installed at low temperatures for a prolonged period. the problem may occur if the lsu with a nimh battery, or the nimh battery itself, when the core temperature of the battery is low, typically between 0°c and 9°c. if used with a nimh battery with low core temperature, the lsu may shut off after some seconds when operated at 350 mmhg or 500+ mmhg (46.6 kpa or 66.5+ kpa) settings. if nimh battery has been stored at temperatures above 9 °c, and used at low temperatures, use should not be affected.
  • 조치
    Laerdal is providing users with the optimised vacuum settings depending on the battery core temperature. Users are advised to install or store the batteries in locations where temperatures are above 9°C.

Device

Mutiple Laerdal Suction Units (LSU) with NiMH Battery
  • 모델명 / 제조번호(시리얼번호)
    Mutiple Laerdal Suction Units (LSU) with NiMH BatteryLSU with Resuable Canister Product Code: 78000003 LSU with Abbot Receptal canister Product Code: 78001003 LSU with Bemis Canister Product Code: 78002001 LSU with Serres Suction Bag Canister System Product Code: 78003003 All serial numbers affectedARTG Number: 129688
  • Manufacturer
    Laerdal Pty Ltd

Manufacturer

Laerdal Pty Ltd