Events

Rappel de Device Recall Powerheart 9300D automated external defibrillator

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
    53827
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0767-2010
  • Date de mise en oeuvre de l'événement
    2009-11-13
  • Date de publication de l'événement
    2010-03-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86618
  • 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
    Potential for devices not to deliver therapy.
  • Action
    Cardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures. For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.

Device

Device Recall Powerheart 9300D automated external defibrillator
  • Modèle / numéro de série
    SERIAL NUMBERS: 378784, 378785, 378786, 378787, 378788, 378789, 378790, 378791, 378792, 378793, 378794, 378795, 378796, 378797, 378798, 378799, 378800, 378801, 378802, 378803, 378804, 378805, 378806, 378807, 378808, 378809, 378810, 378811, 378812, 378813, 378814, 378815, 378816, 378817, 378818, 378819, 378820, 378821, 378822, 378823, 378824, 378825, 378826, 378827, 378828, 378829, 378830, 378831, 378832, 378833, 378834, 378835, 378836, 378837, 378838, 378839, 378840, 378841, 378842, 378843, 378844, 378845, 378846, 378847, 378848, 378849, 378850, 378851, 378852, 378853, 378854, 378855, 378856, 378857, 378858, 378859, 378860, 378861, 378862, 378863, 378864, 378865, 378866, 378867, 378868, 378869, 378870, 378871, 378872, 378873, 378874, 378875, 378876, 378877, 378878, 378879, 378880, 378881, 378882, 378883, 378984, 378985, 378986, 378987, 378988, 378989, 378990, 378991, 378992, 378993, 378994, 378995, 378996, 378997, 378998, 378999, 379000, 379001, 379002, 379003, 379004, 379005, 379006, 379007, 379008, 379009, 379010, 379011, 379012, 379013, 379014, 379015, 379016, 379017, 379018, 379019, 379020, 379021, 379022, 379023, 379024, 379025, 379026, 379027, 379028, 379029, 379030, 379031, 379032, 379033, 379034, 379035, 379036, 379037, 379038, 379039, 379040, 379041, 379042, 379043, 379044, 379045, 379046, 379047, 379048, 379049, 379050, 379051, 379052, 379053, 379054, 379055, 379056, 379057, 379058, 379059, 379060, 379061, 379062, 379063, 379064, 379065, 379066, 379067, 379068, 379069, 379070, 379071, 379072, 379073, 379074, 379075, 379076, 379077, 379078, 379079, 379080, 379081, 379082 and 379083.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.
  • Description du dispositif
    Cardiac Science Powerheart 9300D 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). || Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • 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