Events

Rappel de Device Recall LIFEPAK 12 Defibrillator/MonitorAC Power Adapter

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
    57563
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1548-2011
  • Date de mise en oeuvre de l'événement
    2010-10-01
  • Date de publication de l'événement
    2011-03-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96630
  • 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
    L1fepak 12 operating instructions that describe the process for disconnecting the device from ac (wall) power are not always being followed. when the instructions are not followed and the power on button is pushed within 2 seconds after disconnecting the device from ac power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing.
  • Action
    Physio Control, Inc. began mailing the URGENT-MEDICAL DEVICE INFORMATION letter to their consignees on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were advised to follow the current LIFEPAK 12 Operating Instructions-Section 7.5-AC Power Adapter Operation and wait at least 2 seconds to push the Power ON button after disconnecting the device from AC power. If the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power and the service indicator illuminates, it's important to be aware that turning the device off, then back on again, will reset the device and restore full functionality. The complete copy of the current LIFEPAK 12 Operating Instructions can be downloaded from the company's website at www.physio-control.com/products/ defibrillators, Select LIFEPAK 12, Select Documents. The consignees can call the firm's Technical Support Team at 1-800-442-1142, option 5, between 6:00 A.M. to 4:00 P.M. (Pacific), Monday - Friday.

Device

Device Recall LIFEPAK 12 Defibrillator/MonitorAC Power Adapter
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.Devices were distributed to the following countries: ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.
  • Description du dispositif
    The LIFEPAK12 Defibrillator/Monitor. || The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a defibrillation shock is needed by looking at the ECG rhythm display. Advisory mode can be useful during monitoring; CPSS (Continuous Patient Surveillance System) runs in the background and alerts the operator when a shockable rhythm is detected.
  • 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