Events

Rappel de Welch Allyn AED 20 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 MRL, Inc., A Welch Allyn Company.

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
    31934
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0806-05
  • Date de mise en oeuvre de l'événement
    2005-04-28
  • Date de publication de l'événement
    2005-05-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-09-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38777
  • 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
    The welch allyn aed 20 product may display a 'defib comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ecg and deliver the appropiate therapy.
  • Action
    Urgent Medical Device Recall letters dated 04/28/2005 were sent to the direct accounts informing them of the possibility in a terminal failure due to the radio frequency interference generated inside the AED 20 resulting from an intermittent electrical short. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.

Device

Welch Allyn AED 20 Defibrillator
  • Modèle / numéro de série
    Serial numbers 201887, 204213, 205309, 205857, 205869, 205870, 205871, 205872, 205873, 205874, 205875, 205876, 205877, 205878, 206073, 206075, 206076, 206077, 206078, 206079, 206080, 206081, 206094, 206096, 206097, 206098, 206101, 206111, 206112, 206113, 206114, 206115, 206116, 206117, 206118, 206119, 206120, 206122, 206123, 206124, 206125, 206126, 206127, 206128, 206129, 206130, 206131, 206132, 206133, 206136, 206137, 206138, 206139, 206140, 206141, 206142, 206143, 206144, 206145, 206146, 206147, 206149, 206150, 206151, 206152, 206153, 206154, 206159, 206160, 206162, 206163, 206164, 206165, 206167, 206168, 206169, 206170, 206171, 206172, 206173, 206174, 206175, 206176, 206177, 206178, 206179, 206180, 206181, 206182, 206183, 206184, 206185, 206186, 206187, 206188, 206189, 206190, 206191, 206192, 206193, 206194, 206195, 206196, 206197, 206198, 206199, 206200, 206201, 206202, 206203, 206204, 206205, 206206, 206207, 206208, 206209, 206210, 206212, 206213, 206214, 206215, 206216, 206217, 206218, 206219, 206220, 206221, 206222, 206223, 206224, 206225, 206226, 206227, 206228, 206229, 206230, 206231, 206232, 206233, 206234, 206235, 206236, 206237, 206238, 206239, 206240, 206241, 206242, 206243, 206244, 206245, 206246, 206247, 206248, 206249, 206250, 206251, 206252, 206253, 206254, 206255, 206256, 206257, 206258, 206259, 206260, 206261, 206262, 206264, 206265, 206266, 206267, 206268, 206269, 206270, 206271, 206272, 206273, 206274, 206275, 206276, 206277, 206278, 206279, 206280, 206281, 206282, 206284, 206285, 206286, 206287, 206289, 206290, 206291, 206292, 206293, 206294, 206295, 206296, 206297, 206298, 206299, 206300, 206301, 206302, 206303, 206304, 206305, 206306, 206307, 206308, 206309, 206310, 206311, 206312, 206313, 206314, 206315, 206316, 206317, 206318, 206319, 206320, 206321, 206322, 206323, 206324, 206326, 206328, 206329, 206331, 206332, 206333, 206334, 206335, 206336, 206337, 206338, 206339, 206340, 206342, 206343, 206344, 206345, 206346, 206347, 206348, 206349, 206350, 206351, 206352, 206353, 206354, 206355, 206356, 206357, 206358, 206359, 206360, 206361, 206362, 206363, 206364, 206365, 206366, 206367, 206368, 206369, 206370, 206372, 206373, 206374, 206375, 206376, 206377, 206378, 206379, 206380, 206381, 206382, 206383, 206384, 206385, 206386, 206387, 206388, 206390, 206391, 206392, 206394, 206395, 206396, 206397, 206398, 206399, 206400, 206401, 206402, 206403, 206404, 206405, 206406, 206407, 206408, 206409, 206410, 206411, 206412, 206414, 206415, 206416, 206417, 206418, 206419, 206420, 206421, 206422, 206423, 206424, 206425, 206426, 206427, 206428, 206429, 206430, 206431, 206432, 206433, 206434, 206435,  206436, 206438, 206439, 206441, 206442, 206443, 206444, 206445, 206446, 206447, 206448, 206449, 206450, 206451, 206452, 206453, 206454, 206455, 206456, 206457, 206458, 206459, 206460, 206461, 206462, 206463, 206464, 206465, 206466, 206467, 206468, 206469, 206470, 206471, 206472, 206473, 206474, 206475, 206477, 206478, 206479, 206480, 206481, 206482, 206483, 206484, 206485, 206486, 206487, 206488, 206489, 206490, 206491, 206492, 206493, 206494, 206495, 206496, 206497, 206498, 206499, 206500, 206501, 206503, 206504, 206505, 206506, 206507, 206508, 206509, 206510, 206511, 206512, 206513, 206514, 206515, 206516, 206517, 206518, 206519, 206520, 206521, 206522, 206523, 206524, 206525, 206526, 206527, 206528, 206529, 206530, 206531, 206532, 206533, 206534, 206535, 206536, 206537, 206538, 206539, 206540, 206541, 206542, 206543, 206544, 206545, 206546, 206547, 206548, 206549, 206550, 206551, 206552, 206553, 206554, 206555, 206556, 206557, 206558, 206559, 206560, 206561, 206562, 206563, 206564, 206565, 206566, 206567, 206568, 206569, 206570, 206571, 206572, 206573, 206574, 206576, 206577, 206578, 206579, 206580, 206581, 206582, 206583, 206584, 206585, 206586, 206587, 206588, 206589, 206590, 206591, 206592, 206593, 206594, 206595, 206597, 206598, 206599, 206600, 206601, 206602, 206603, 206604, 206605, 206606, 206607.206608, 206609, 206610, 206611, 206612, 206613, 206614, 206615, 206616, 206618, 206619, 206620, 206621, 206622, 206623, 206624, 206625, 206626, 206627, 206628, 206629, 206630, 206632, 206633, 206634, 206635, 206636, 206637, 206638, 206639, 206640, 206641, 206642, 206643, 206644, 206645, 206646, 206647, 206648, 206649, 206650, 206651, 206652, 206653, 206654, 206655, 206656, 206657, 206658, 206659, 206660, 206661, 206662, 206663, 206664, 206665, 206666, 206667, 206668, 206669, 206670, 206671, 206672, 206673, 206674, 206675, 206676, 206677, 206678, 206679, 206680, 206681, 206682, 206683, 206684, 206685, 206686, 206687, 206688, 206689, 206690, 206691, 206693, 206694, 206695, 206696, 206697, 206698, 206699, 206700, 206701, 206702, 206703, 206704, 206705, 206706, 206707, 206708, 206709, 206710, 206711
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Australia, Canada, China, France, Germany, Ireland, Israel, Malaysia, the Middle East, New Zealand, the Philippines, Poland, Singapore, South America, South Korea, Switzerland and the United Kingdom.
  • Description du dispositif
    Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part number 972200E
  • Manufacturer
    MRL, Inc., A Welch Allyn Company

Manufacturer

MRL, Inc., A Welch Allyn Company
  • Adresse du fabricant
    MRL, Inc., A Welch Allyn Company, 1000 Asbury Dr Ste 17, Buffalo Grove IL 60089-4551
  • Source
    USFDA