Lifepak 500 AED

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    BAM

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Cases do not contain serial numbers or lot numbers. Catalog number 3005384-000 through 002
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Cases were distributed nationwide and internationally.
  • 제품 설명
    Hard shell carry case for the LIFEPAK 500 AED.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical electronics / Electromedical devices
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Bahamas, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Iran, Japan, Mexico, Netherlands, Peru, and Uruguay.
  • 제품 설명
    The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. || This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient. || The LIFEPAK 500 AED is intended for use in the pre-hospital and workplace and community environments. It has been tested to RTCA/DO-160D; "Environmental Conditions and Test Procedures for Airborne Equipment" (refer to Specifications on page 5-15 of the Operating Instructions 3005338-001). The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training: -CPR training -AED training equivalent to that recommended by the American Heart Association -Training in the use of the LIFEPAK 500 AED.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: (Lot serial: 3005384-000 THROUGH -002)
  • 제품 설명
    LIFEPAK 500 HARD-SHELL CASE
  • Manufacturer