LIFEPAK 12 DEFIBRILLATOR/MONITOR

Fabricant

  • Adresse du fabricant
    BRAMPTON
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    HC

13 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544.  SERIAL NUMBERS OF DEVICES:  32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
  • Description du dispositif
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. || The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). || The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 43400-XXXXXX (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 99400-XXXXXX (Lot serial: >10 NUMBERS CONTACT MFR)
  • Description du dispositif
    LIFEPAK 12 DEFIBRILLATOR/MONITOR
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: LP 12 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Description du dispositif
    LIFEPAK 12 DEFIBRILLATOR/MONITOR
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: LP12 (Lot serial: SN 35489447); Model Catalog: 70402 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Description du dispositif
    LIFEPAK 12 DEFIBRILLATOR/MONITOR
  • Manufacturer
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