Events

Rappel de Device Recall LIFEPAK 1000 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 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
    76252
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1257-2017
  • Date de mise en oeuvre de l'événement
    2017-01-13
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152589
  • 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 firm has received complaints that the lifepak 1000 defibrillator is unexpectedly powering off during device usage.
  • Action
    Physio Control sent an Urgent Medical Device Correction letter dated January 2017 to all affected customers. The firm issued the press release on January 13, 2017. The link to press release is http://www.fda.gov/Safety/Recalls/ucm537114.htm. The firm also started mailing letter, confirmation sheet, check list to consignees on January 13, 2017. Information about this notice is available at: www.physio-control.com/lifepak1000-274. Customers were instructed to immediately remove and reinstall the battery from their LIFEPAK 1000 defibrillator. The removal and reinstallation of the battery will clean the contacts of oxidation and will restore power to the device. It is critically important that customers implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. Removing and reinstalling the battery on a weekly basis will help ensure their device is ready for use. Customers were also advised to always carry a spare, fully charged battery. The weekly schedule of battery removal must be performed until their device correction has been completed. Customers were asked to forward this information to all of their sites, trainers and users who have LIFEPAK 1000 devices. The Customer Letter was updated on the web page to clarify the statement "It is also important to always carry a spare, fully charged battery" was provided as a reminder to customers and is consistent with what is stated in the LIFEPAK 1000 Defibrillator Operating Instructions. Customers were asked to complete and return the Confirmation Sheet to Physio-Control. Customers with questions regarding this notification, please contact Physio-Control by calling 1-866-231-1220, 6:00 a.m. to 4:00 p.m. (Pacific) Monday  Friday, or by email to rsrecalls@physio-control.com or fax to 1-866-448-9567.

Device

Device Recall LIFEPAK 1000 defibrillator
  • Modèle / numéro de série
    Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia, Ukraine, and Zambia.
  • Description du dispositif
    The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
  • 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