Events

Battery Pack portion of the LifeVest device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zoll Lifecor Corporation 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
    44942
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0061-2008
  • 사례 시작날짜
    2007-09-14
  • 사례 출판 날짜
    2007-10-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-06-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64559
  • 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
    battery - Product Code MVK
  • 원인
    Possible malfunction of the battery pack. a significant electrostatic discharge (esd) can cause the battery pack to malfunction. the malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.
  • 조치
    Patients currently using the LifeVest should continue to do so while the product removal is underway. Advisory notices will be sent via first class mail 9/14/2007 to all active patients using the LifeVest device. Product replacements began on 8/31/07 by shipping out revised battery packs for new patient use. Shipments of new battery packs will continue based on production capacity and material availability. Any patients expected to be using the device longer than 5 months will be provided with 2 replacement Battery Packs. They will be instructed to return their existing packs in the same shipping box.

Device

Battery Pack portion of the LifeVest device
  • 모델명 / 제조번호(시리얼번호)
    Product number 10A0894-A01. Serial numbers 71000101 through 71003176.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    The product was shipped nationwide to patients. The product was also shipped to distributors in Germany, United Kingdom, Italy, Spain, France, and Denmark.
  • 제품 설명
    Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).
  • Manufacturer
    Zoll Lifecor Corporation

Manufacturer

Zoll Lifecor Corporation
  • 제조사 주소
    Zoll Lifecor Corporation, 121 Freeport Rd, Pittsburgh PA 15238-3411
  • Source
    USFDA