Events

Rappel de Device Recall LIFEPAK15 monitor/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
    73473
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1993-2016
  • Date de mise en oeuvre de l'événement
    2016-01-27
  • Date de publication de l'événement
    2016-06-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144259
  • 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 became aware that when using etc02 in the kpa or % setting and in a situation where the reading is above 9.9 kpa, the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etc02 value. this affects all lifepak 15 with an etc02 feature installed and configured to the kpa or % setting.
  • Action
    Physio-Control sent the letter with the title Information Regarding LIFEPAK 15 MONITOR/DEFIBRILLATOR WITH End-tidal CO2 OPTION, dated January 2016, to customers in the United Kingdom (UK) as REQUESTED by the Medicines and Healthcare product Regulatory Agency (MHRA) on January 27, 2016. Physio initiated a voluntary field action on February 23, 2016 and started notifying US consignees on March 22, 2016 and started notifying international consignees on April 18, 2016. The Information Regarding LIFEPAK 15 MONITOR/ DEFIBRILLATOR WITH End-tidal CO2 OPTION letter, dated March 2016, was sent. Customer Letters began mailing in EMEA region, beginning on 06/20/2016 via designated Courier. Customer Letters began mailing in Canada on 09/09/2016 via FedEx. Customer Letters began mailing in Latin America on 09/16/2016 via email. Customer Letters began mailing in APAC region on 09/22/2016 via email. Second Customer letters with Confirmation Sheets began mailing in the US October 2016 via FedEx and USPS Certified Mail. Actions should be taken by users: 1. Please forward this information to all of your sites, trainers and users that may have a LIFEPAK 15 monitor/defibrillator. 2. If you use your LIFEPAK 15 monitor/defibrillator to display EtC02 values you should also display the EtC02 waveform which includes the range along the right side of the display. 3. If you use either kPa or % settings, activate EtC02 alarms to identify EtC02 values outside the normal range. 4. If your protocols allow this option, consider changing the EtC02 to measure in the mmHg setting. The firm reported that the revised software for LifePak15 version 4 (v4) and the customer install instructions would be available on LIFENET by April 25, 2016. The revised software for LifePak 15 versions 1 and 2 (v1 and v2) and the customer install instructions are estimated to be available on LIFENET in mid May 2016. Customers who have any questions about this subject, please contac

Device

Device Recall LIFEPAK15 monitor/defibrillator
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Eritrea, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guinea, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Papua New Guinea, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.
  • Description du dispositif
    LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. || Part numbers: || V15-2-xxxxxx (includes software version 1 and version 2); || V15-5-xxxxxx (inclues software version 4). || The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
  • 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