Events

Rappel de Device Recall LIFEPAK 12 DEFIBRILLATOR/MONITOR

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 Physio Control, Inc..

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
    54005
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0811-2010
  • Date de mise en oeuvre de l'événement
    2009-03-31
  • Date de publication de l'événement
    2010-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87123
  • 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
    Affected devices contain a biphasic pcba that may have a solder defect on the h bridge component that could prevent the device from providing a defibrillation shock. there could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. delay or prevention of defibrillation therapy may contribute to the death of a viable patient.
  • Action
    Consignees were sent a notification letter dated March 2009 that explained firm representatives would follow up with each customer within 30 days to arrange an update to affected devices. Affected Biphasic PCBAs will be replaced. Customers advised to keep the devices in use and to continue to perform daily User Test.

Device

Device Recall LIFEPAK 12 DEFIBRILLATOR/MONITOR
  • Modèle / numéro de série
    Part Number: LP12, VLP12-02-(various dash numbers).  Serial Numbers (non-contiguous): 8529728, 8529728, 9210418, 9210419, 9599334, 10128750, 10132851, 10248200, 10389064, 11120818, 11244332, 11252979, 11252980, 11252981, 11289300, 11311777, 11311778, 11311782, 11311787, 11316922, 11372139, 11424301, 11424819, 11471546, 11568711, 11610477, 11766215, 11766216, 11766222, 11767531, 11767565, 11877154, 12007118, 12007124, 12007129, 12007131, 12007135, 12009524, 12009528, 12030152, 12209828, 12209830, 12209832, 12209834, 12551932, 12551934, 12551936, 12551937, 12551939, 12776733, 12776734, 12779439, 12779439, 12789243, 13165363, 13269232, 13423039, 13434816, 13434837, 13522303, 13536842, 13704769, 13704770, 13870608, 13993048, 14008074, 14008075, 14201185, 14201186, 14201187, 30646561, 32117838, 32117838, 32117839, 32117839, 32117840, 32117840, 37125611, 37125612, 37125617, 37125743, 37125751, 37125752, 37125753, 37126327, 37126328, 37126329, 37126330, 37126331, 37126332, 37126333, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Distributed domestically and internationally to hospitals, clinics, etc. Foreign distribution to the following countries: Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico.
  • Description du dispositif
    Biphasic LIFEPAK 12 defibrillator / monitor.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Adresse du fabricant
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA