Events

Rappel de Device Recall Cardiovive AED

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 Cardiac Science Corporation.

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
    54517
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1249-2010
  • Date de mise en oeuvre de l'événement
    2010-02-03
  • Date de publication de l'événement
    2010-04-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88622
  • 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 of the aed device may fail during a rescue attempt and the aed will not be able to deliver therapy.
  • Action
    The firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website. Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardiacscience.com to arrange for replacement(s).

Device

Device Recall Cardiovive AED
  • Modèle / numéro de série
    SERIAL NUMBER:  4104049
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries: AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TRINIDAD, AND GREAT BRITAIN.
  • Description du dispositif
    Cardiovive 92532 automated external defibrillator. || This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). || Brand name: Burdick. || Product name: Cardiovive. || Device Operation: Semi-automatic. || Color: Blue. || Voice Prompt Level: Basic. || CPR Metronome: No. || Rescue Ready Indicator: Yes. || Text Display: Yes. || ECG Display: No.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Adresse du fabricant
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Société-mère du fabricant (2017)
    Cardiac Science Corporation
  • Source
    USFDA