Events

Rappel de Respironics Trilogy 100, 200 and 202 Ventilators

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 Respironics, 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
    60099
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0296-2012
  • Date de mise en oeuvre de l'événement
    2011-10-11
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104431
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Cause
    Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. if the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. this may impact therapy.
  • Action
    Philips Healthcare, began notifying customers via telephone on October 11, 2011. The telephone notification discussed the product, problem and actions to be taken. The customers were instructed to not remove a ventilator from a patient without providing a replacement unit; provide a fax number or email address Philips can use to send the Business Reply Form to complete and return via fax to: 800-733-9962 or email: report.request@philips.com; locate their affected devices (if the device is with a patient, replace it with a non-affected unit-Philips will provide a loaner overnight if needed)-(if the device is in their inventory, quarantine it and return it using the RA number provided in the email/fax that Philips sends them); and If loaner units are needed, they are to call 1-877-387-3311 to arrange return of your affected device and to obtain a loaner unit. If you have any questions or concerns, contact Philips Respironics at 877-387-3311.

Device

Respironics Trilogy 100, 200 and 202 Ventilators
  • Modèle / numéro de série
    Serial Numbers: GV111030238, GV111040533, GV111040627, GV111040632, GV111040640, GV111040651, GV111040652, GV111040653, TV011031510, TV011040511, TV011040516, TV011040518, TV011040524, TV011040529, TV011040530, TV011040601, TV011040602, TV011040609, TV011040615, TV109081805, TV109081806, TV109081807, TV111021835, TV111022551, TV0111022832, TV111030422, TV111030441, TV111030445, TV111030453, TV111030774, TV111030790, TV111030853, TV111030932, TV111030947, TV111030976, TV111030978, TV111031001, TV111031011, TV111031037, TV111031045, TV111031057, TV111031064, TV111031067, TV111031113, TV111031403, TV111031413, TV111031420, TV111031462, TV111031554, TV111032252, TV111032254, TV111032306, TV111032316, TV111032562, TV111032809, TV111032811, TV111032812, TV111032822, TV111032827, TV111032829, TV111032830, TV111032832, TV111032833, TV111032901, TV111032905, TV111032906, TV111032909, TV111032912, TV111032913, TV111032914, TV111032920, TV111032923, TV111032924, TV111032925, TV111032926, TV111032929, TV111032934, TV111032935, TV111032938, TV111032939, TV111032940, TV111033001, TV111033004, TV111033005, TV111033006, TV111033009, TV111033010, TV111033016, TV111033018, TV111033019, TV111040110, TV111040113, TV111040117, TV111040404, TV111040405, TV111040411, TV111040415, TV111040416, TV111040418, TV111040419, TV111040420, TV111040423, TV111040424, TV111040428, TV111040432, TV111040438, TV111040703, TV111040729, TV111040735, TV111040803, TV111040808, TV111040830, TV111041118, TV111041304, TV111041306, TV111041435, TV111041436, TV211032405, TV211032409, TV211032412, TV211032413, TV211032414, TV211032415, TV211032419, TV211032420, TV211032430, TV211032431
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, GA, ID, IL, KS, MI, MO, NE, NV, NJ, OH, PA, TN, and TX; and countries of: Australia, Austria, Canada, China, Denmark, Germany, Great Britain, India, Italy, Japan, Korea (Republic of [South] Korea), Netherlands, Philippines, Saudi Arabia, Spain (Espana), and Turkey.
  • Description du dispositif
    Trilogy 100, 200 and 202 Ventilators || The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Adresse du fabricant
    Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668-8517
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA