Events

Rappel de Device Recall defibrillator/monitor

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Physio Control, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    55875
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1722-2011
  • Date de mise en oeuvre de l'événement
    2010-05-27
  • Date de publication de l'événement
    2011-03-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92116
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    A component failure on the ac power supply assembly results in "no ac power" operation. a failure of ac power can result in a delay of defibrillation therapy if backup battery power is depleted.
  • Action
    PhysioControl, Inc. began sending an Urgent Medical Device Correction letter via certified receipt to all affected customers describing the potential issue. Customers were advised to keep the defibrillators in service and to follow the daily Operator's Checklist. All power supplies will be updated. For questions customers were instructed to contact Technical Support at 1-800-442-1142. For questions regarding this recall call 425-867-4000.

Device

Device Recall defibrillator/monitor
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MI, MD, MI, NC, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY and the coutnries of ANGUILLA, ARGENTINA, AUSTRALIA, BAHAMAS, BAHRAIN, BARBADOS, BOLIVIA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, GERMANY, GUAM, GUATEMALA, HONG KONG, INDIA, IRAN, ISRAEL, JAMAICA, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PUERTO RICO, SAUDI ARABIA, SOUTH AFRICA, SYRIA, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIRGIN ISLANDS, and YEMEN.
  • Description du dispositif
    The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000. || The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e are acute cardiac care devices used by authorized healthcare providers in hospital and clinic settings. It is commonly found on "code" or "crash" cars in hospital hallways, plugged into AC power. In an emergency the user retrieves the cart, unplugging the monitor, and uses the device with the door closed for easy 1-2-3 operation. When the code team arrives the user will open the door and have access to all functions, including ECG monitoring. In addition to functioning as a semi-automatic defibrillator the LIFEPAK 20/20e provides options for: ECG monitoring, manual mode defibrillation; Non-invasive pacing; synchronized cardioversion; pulse oximetry (SpO2); hard paddles (adult and pediatric) and internal paddle accessories; printing; and backup batter power. The units are biphasic waveform devices
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Adresse du fabricant
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA