Events

Device Recall FASTPAK 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Physio Control, 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
    46921
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1567-2008
  • 사례 시작날짜
    2008-02-27
  • 사례 출판 날짜
    2008-08-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68503
  • 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, External Automatic Defibrillator - Product Code MKJ
  • 원인
    Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.
  • 조치
    On February 27, 2008, the firm sent a "URGENT MEDICAL DEVICE - ACCESSORY RECALL" letter via certified return receipt to their consignees. The letter states the batteries are fully functional 1.0 amp/hour batteries mislabeled as 2.4 amp/hour batteries and that the batteries will provide half the monitoring time and half the number of defibrillation shock as of a 2.4 amp/hour LIFEPAK NiCd battery. Enclosed with the letter is a confirmation sheet for the consignee to indicate the number of recalled batteries they have and fax back to the firm. The firm will send out replacement batteries and the consignee is to then send back the mislabeled batteries. If there are any questions, contact the technical support group at 1-800-442-1142 - option 5 or visit www.physio-control-notices.come/fastpak.

Device

Device Recall FASTPAK
  • 모델명 / 제조번호(시리얼번호)
    All batteries with lot code 0624.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Batteries were distributed nationwide and to Canada, Netherlands, Asia Pacific and Latin America.
  • 제품 설명
    FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redmond, WA USA. Batteries are Nickel-Cadmium (NiCd) battery packs used to provide DC power to LIFEPAK 5, 10, 11, or 12 defibrillator/monitors. The FASTPAK battery has a capacity of 1 amp/hour (1.0AH). The FASTPAK battery can be charged in a Battery Support System, Battery Support System 2, Mobile Battery Service Station, or the LIFEPAK 10, 11 or 12 defibrillator/monitor when the device is powered by an external power adapter. The FASTPAK battery does not have a pushbutton fuel gauge like the LIFEPAK NiCd. The fuel gauge provides a visual indication of battery capacity. || Battery part number 9-10424-18. Sold with LIFEPAK defibrillators and also sold separately.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • 제조사 주소
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA