Events

Device Recall LIFEPAK CR Plus and/or LIFEPAK EXPRESS 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
    74198
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2100-2016
  • 사례 시작날짜
    2016-05-25
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146712
  • 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 defibrillators (non-wearable) - Product Code MKJ
  • 원인
    Lifepak cr plus automated external defibrillators (aed) or lifepak express aed may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. a defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated.
  • 조치
    The firm, Physio Control, sent an "URGENT MEDICAL DEVICE CORRECTION-ACTION REQUIRED"- LifePak CR Plus AE and LifePak Express AED letter and the Confirmation sheet, dated May 2016, to US customers on 5/25/16. Physio will notify international consignees during the week of 6/13/16. The letter described the product, problem and the actions to be taken. The customers were instructed to-URGENTLY bring this letter to the immediate attention of the person(s) responsible for maintaining/monitoring your Automated External Defibrillators (AEDs); follow the instructions on the Confirmation Sheet that outline specific actions to take for the serial numbers listed, and if you have a routine check process, please continue this process. If you have not established a routine check process, please refer to section 5 of the Operating Instructions for recommended actions. In addition, customers should follow the instructions on the Confirmation Sheet and submit this form to Physio by: -Fax to: 1-866-448-9567 -Email to: rsrecall@physio-control.com -Mail to: Physio-Control, Inc. P.O. Box 970006, Dept. 15N Redmond, WA, 98073-9706 Physio-Control will contact customers with LIFEPAK CR Plus and LIFEPAK EXPRESS AEDs that contain the affected reed switch assembly. A device correction including provision of loaner devices and replacement of the reed switch component will be arranged for all affected devices. Customers who have any questions regarding this notification, please call Physio-Control at 1-800-442-1142, 6:00 a.m. to 4:00 p.m. (Pacific), Monday  Friday.

Device

Device Recall LIFEPAK CR Plus and/or LIFEPAK EXPRESS
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and countries of: Argentina, Austria, Australia, Bahamas, Bangladesh, Belgium, Brazil, Brunei Darussalami, Canada, Chile, China, Croatia, Cyprus. Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan (Province of China), Turkey, United Arab Emirates, United Kingdom, New Caledonia, and New Zealand,.
  • 제품 설명
    LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. || LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
  • 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