Events

Device Recall LIFEPAK15 monitor/defibrillator 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
    73473
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1993-2016
  • 사례 시작날짜
    2016-01-27
  • 사례 출판 날짜
    2016-06-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144259
  • 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
    The firm became aware that when using etc02 in the kpa or % setting and in a situation where the reading is above 9.9 kpa, the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etc02 value. this affects all lifepak 15 with an etc02 feature installed and configured to the kpa or % setting.
  • 조치
    Physio-Control sent the letter with the title Information Regarding LIFEPAK 15 MONITOR/DEFIBRILLATOR WITH End-tidal CO2 OPTION, dated January 2016, to customers in the United Kingdom (UK) as REQUESTED by the Medicines and Healthcare product Regulatory Agency (MHRA) on January 27, 2016. Physio initiated a voluntary field action on February 23, 2016 and started notifying US consignees on March 22, 2016 and started notifying international consignees on April 18, 2016. The Information Regarding LIFEPAK 15 MONITOR/ DEFIBRILLATOR WITH End-tidal CO2 OPTION letter, dated March 2016, was sent. Customer Letters began mailing in EMEA region, beginning on 06/20/2016 via designated Courier. Customer Letters began mailing in Canada on 09/09/2016 via FedEx. Customer Letters began mailing in Latin America on 09/16/2016 via email. Customer Letters began mailing in APAC region on 09/22/2016 via email. Second Customer letters with Confirmation Sheets began mailing in the US October 2016 via FedEx and USPS Certified Mail. Actions should be taken by users: 1. Please forward this information to all of your sites, trainers and users that may have a LIFEPAK 15 monitor/defibrillator. 2. If you use your LIFEPAK 15 monitor/defibrillator to display EtC02 values you should also display the EtC02 waveform which includes the range along the right side of the display. 3. If you use either kPa or % settings, activate EtC02 alarms to identify EtC02 values outside the normal range. 4. If your protocols allow this option, consider changing the EtC02 to measure in the mmHg setting. The firm reported that the revised software for LifePak15 version 4 (v4) and the customer install instructions would be available on LIFENET by April 25, 2016. The revised software for LifePak 15 versions 1 and 2 (v1 and v2) and the customer install instructions are estimated to be available on LIFENET in mid May 2016. Customers who have any questions about this subject, please contac

Device

Device Recall LIFEPAK15 monitor/defibrillator
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Eritrea, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guinea, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Papua New Guinea, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.
  • 제품 설명
    LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. || Part numbers: || V15-2-xxxxxx (includes software version 1 and version 2); || V15-5-xxxxxx (inclues software version 4). || The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
  • 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