Events

Rappel de HeartStart 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 Philips Medical Systems.

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
    47833
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1780-2008
  • Date de mise en oeuvre de l'événement
    2008-04-30
  • Date de publication de l'événement
    2008-07-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70292
  • 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
    Defibrillator - Product Code MKJ
  • Cause
    Buttons sticking - the on/off and shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock.
  • Action
    Three separate Urgent - Device Recall letter were sent out on April 30, 2008 via tractable letter using UPS. 1) The end-customer letter advises of the recall, contact information to arrange a replacement of the device and instructions for checking the equipment to insure it is working correctly. "If your HeartStart Home Defibrillator is one of the affected devices or if you have any questions about this recall, please contact Philips Healthcare at 1.800.263.3342, option 5, or visit www.HeartStartHome.com to arrange for a free replacement defibrillator. If you have given your HeartStart to someone else as a gift, please call us promptly and let us know how to contact that person to arrange for the replacement. While waiting for your replacement unit, Philips recommends that you perform a battery insertion test (BLT) of your HeartStart, as described in the Owner's Manual provided with it. Simply remove the battery, wait 5 seconds, reinstall the battery, then press the shock button when directed. After the BIT has finished, press the green On/Off button twice. If either button does not seem to work, please contact Philips immediate." 2) The dealer/distributor and retail letters advises of the recall; request that the dealer/distributor provide end-customer information. "As part of a coordinated effort involving notification of regulatory authorities, other Philips entities, and support personnel, Philips will be contacting all affected customers directly. It is not necessary for you or your sub-distributors to contact customers." 3) The international customer contacts will be made via established Philips sales and distribution channels. Philips will be replacing international units under a Field Change Order Process (to be provided by the firm). In addition, Philips will provide a website that will provide customers with information related to the recall (www.HeartStartHome).

Device

HeartStart defibrillator
  • Modèle / numéro de série
    SN for Laedal "HeartStart Defibrillator": A05I-00051, A05I-00091, A05I-00103, A05I-00125, A05I-00178, A05I-00208, A05I-00211, A05I-00224, A05I-00263, A05I-00283, A05I-00285, A05I-00288, A05I-00289, A05I-00294, A05I-00295, A05I-00297, A05I-00298, A05I-00299, A05I-00300, A05I-00317, A05I-00324, A05I-00346, A05I-00351, A05I-00352, A05I-00353, A05I-00354, A05I-00355, A05I-00356, A05I-00357, A05I-00358, A05I-00359, A05I-00360, A05I-00361, A05I-00362, A05I-00363, A05I-00364, A05I-00365, A05I-00366, A05I-00367, A05I-00368, A05I-00369, A05I-00370, A05I-00371, A05I-00372, A05I-00373, A05I-00374, A05I-00375, A05I-00376, A05I-00377, A05I-00378, A05I-00379, A05I-00380, A05I-00381, A05I-00382, A05I-00383, A05I-00384, A05I-00385, A05I-00386, A05I-00387, A05I-00388, A05I-00389, A05I-00390, A05I-00391, A05I-00392, A05I-00393, A05I-00394, A05I-00395, A05I-00396, A05I-00397, A05I-00398, A05I-00399, A05I-00405, A05I-00451, A05I-00452, A05I-00454, A05I-00455, A05I-00456, A05I-00457, A05I-00458, A05I-00459, A05I-00460, A05I-00462, A05I-00467, A05I-00479, A05I-00488, A05I-00492, A05I-00502, A05I-00507, A05I-00508, A05I-00510, A05I-00519, A05I-00523, A05I-00524, A05I-00532, A05I-00561, A05I-00563, A05I-00598, A05I-00635, A05I-00639, A05I-00641, A05I-00642, A05I-00643, A05I-00647, A05I-00648, A05I-00650, A05I-00706, A05I-00709, A05I-00710, A05I-00711, A05I-00712, A05I-00714, A05I-00715, A05I-00718, A05I-00719, A05I-00720, A05I-00722, A05I-00723, A05I-00742, A05I-00743, A05I-00744, A05I-00746, A05I-00763, A05I-00766, A05I-00767, A05I-00769, A05I-00770, A05I-00774, A05I-00789, A05I-00790, A05I-00795, A05I-00797, A05I-00798, A05I-00809, A05I-00811, A05I-00827, A05I-00854, A05I-00855, A05I-00856, A05I-00860, A05I-00943, A05I-00944, A05I-00970, A05I-00989, A05I-00990, A05I-00991, A05I-01002, A05I-01007, A05I-01027, A05I-01028, A05I-01031, A05I-01036, A05I-01050, A05I-01065, A05I-01068, A05I-01071, A05I-01085, A05I-01095, A05I-01157, A05I-01158, A05I-01246, A05I-01283, A05I-01306, A05I-01346, A05I-01353, A05I-01403, A05I-01415, A05I-01422, A05I-01463, A05I-01497, A05I-01567, A05I-01573, A05I-01577, A05I-01583, A05I-01604, A05I-01625, A05I-01663, A05I-01679, A05I-01704, A05I-01725, A05I-01797, A05I-01838, A05I-01839, A05I-01840, A05I-01874, A05I-01889, A05I-01913, A05I-01981, A05I-01983, A05I-01984, A05I-02002, A05I-02072, A05I-02210, A05I-02324, A05I-02359, A05I-02463, A05I-02524, A05I-02652, A05I-02655, A05I-02672, A05I-02875, A05I-02937, A05I-03167, A05I-03260, A05I-03269, A05I-03421, A05I-03435, A05I-03500, A05I-03533, A05I-03538, A05I-03540, A05I-03627, A05I-03631, A05I-03863, A05I-03884, A05I-03917, A05I-03930, A05I-04017, A05I-04038, A05I-04061, A05I-04066, A05I-04073, A05I-04077, A05I-04078, A05I-04157, A05I-04160, A05I-04193, A05I-04198, A05I-04205, A05I-04248, A05I-04250, A05I-04254, A05I-04257, A05I-04262, A05I-04352, A05I-04469, A05I-04478, A05I-04554, A05I-04583, A05I-04599, A05I-04601, A05I-04615, A05I-04649, A05I-04676, A05I-04691, A05I-04694, A05I-04750, A05I-04751, A05I-04752
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide including USA and countries of Austria, Australia, Canada, Colombia, German, Denmark, Dominican Republic, Spain, France, England, Ireland, Italy, Japan, Netherlands, Norway, New Zealand, Panama, Sweden, Singapore, and South Africa.
  • Description du dispositif
    Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical Corp, Wappingers Falls, NY and is sold outside the U.S. The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Adresse du fabricant
    Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
  • Source
    USFDA