Events

Rappel de Device Recall LIFEPAK

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 Medtronic Physio Control Corp.

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
    27864
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0294-04
  • Date de mise en oeuvre de l'événement
    2003-11-12
  • Date de publication de l'événement
    2004-01-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-02-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30656
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
    unknown device name - Product Code MKI
  • Cause
    Device unable to recognize the connection to the hard paddles accessory.
  • Action
    Beginning on 11/12/03 representatives from the firm visited the consignees and replaced the paddles. A letter dated November 2003 was provided to the consignees.

Device

Device Recall LIFEPAK
  • Modèle / numéro de série
    Part numbers: 3200936-000, 3200936-001, 3200936-003, 3200936-010.   Date codes affected: 19680, 19681, or 19682  The firm shipped sets of paddles with shipments of devices with serial numbers listed. However, a set of paddles was not shipped specifically with each LP 20, and a customer may receive (per order) more devices than paddle sets. The paddles may be used with the devices specified below, or with any other LP 20 device. LP 20 serial numbers shipped: 31481310, 31487712, 31469046, 31480240, 31488466, 31488468, 31488472, 31488479, 31488482, 31488483, 31488485, 31488486, 31488487, 31488491, 31488492, 31488494, 31488495, 31488498, 31488499, 31488500, 31488502, 31488503, 31488505, 31488970, 31488971, 31488976, 31490835, 31490862, 31490864, 31490865, 31490914, 31492668, 31494830, 31494961, 31495055, 31496204, 31496499, 31496500, 31496502, 31497170, 31497171, 31497173, 30540237, 30541490, 30524326, 31405298, 31405302, 31406327, 31406328, 31406329, 31406330, 31407066, 31420549, 31461553, 31461548, 31461559, 31461565, 31451566, 31461568, 31461569, 31461575, 31461576, 31461578, 31461580, 31461583, 31469733, 31469741, 31469747, 31481173, 31481174, 31481261, 31481265, 31481277, 31481279, 31481281, 31490863, 31490913, 31491385, 31491387, 31491390, 31491441, 31491443, 31491445, 31491384, 31491388, 31491442, 31461579, 31491444, 31494875, 31494878, 31494883, 31494884, 31490836, 31492587, 31480230, 31488975, 31494882, 31488501, 31481264, 31409217, 31481262, 31412444, 31488474, 31488470, 31481152, 31481183, 31486080, 31486083, 31488340, 31488343, 31488344, 31495057, 31495686, 31499486, 31481318, 31488973, 31491581, 31469686, 31462754, 31461567, 31461555, 31461564, 31471398, 31462757, 31461558, 31469688, 31492591, 31461574, 31480226, 31462758, 31487665, 31469037, 31469038, 31469039, 31469041, 31469043, 31469044, 31469045, 31469689, 31469690, 31480222, 31480232, 31480234, 31480238, 31469678, 31469719, 31469707, 31469727, 31461560, 31481193, 31486082, 31487666, 31461570, 31469675, 31469677, 31469680, 31469682, 31469704, 31469709, 31469714, 31481269, 31491801, 31492056, 31492128, 31469711, 31469699, 31494874, 31461551, 31493149, 31471394, 31493147, 31480235, 31461577, 31462761, 31462768, 31469670, 31481321, 31488341, 31488342, 31488481, 31488489, 31488490, 31488493, 31488497, 31488504, 31488977, 31491065, 31491580, 31491803, 31492053, 31492588, 31492589, 31492590, 31492667, 31492669, 31493144, 31493146, 31493148, 31494428, 31494430, 31494433, 31494434, 31495056, 31495058, 31495059, 31495409, 31496498, 31501828, 31501829, 31469702, 31448168, 31461573, 31469710, 31469661, 31469684, 31496197, 31481313, 31469726, 31469730, 31462762
  • Classification du dispositif
    Cardiovascular Devices
  • Distribution
    The firm distributed devices to 32 hospitals and medical centers located throughout the United States.
  • Description du dispositif
    LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.
  • Manufacturer
    Medtronic Physio Control Corp

Manufacturer

Medtronic Physio Control Corp
  • Adresse du fabricant
    Medtronic Physio Control Corp, 11811 Willows Rd NE, Redmond WA 98073
  • Source
    USFDA