Device Recall LIFEPAK CR Plus

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA (and Puerto Rico) and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada , Chile, Colombia, Dominica, Germany, Hong Kong, Hungary, Jamaica, Japan, Mexico, Netherlands, New Zealand, Singapore, Uruguay, Venezuela, and Virgin Islands.
  • 제품 설명
    LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. || LIFEPAK CR Plus AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.
  • Manufacturer
  • 2 Events

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 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
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211, 37038365, 37135986, 37154526 and 37154638.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US (DC and MN) and Japan.
  • 제품 설명
    Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. || Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.
  • Manufacturer