Events

Rappel de Device Recall Pneupac VR1

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 Smiths Medical PM, 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
    37968
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0991-2007
  • Date de mise en oeuvre de l'événement
    2007-05-16
  • Date de publication de l'événement
    2007-07-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-10-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52551
  • 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 resuscitator - Product Code BTL
  • Cause
    Smiths medical is conducting a recall of 93 pneupac vr1 emergency & transport ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuous flow output to the patient.
  • Action
    Distriblutors and end users were contacted by phone (May 10 - May 24, 2007) and end users were additionally sent a Safety Action Bulletin May 21, 2007. The Bulletin was used as a script.

Device

Device Recall Pneupac VR1
  • Modèle / numéro de série
    serial number: 06-12-223, 06-12-225, 06-12-226, 06-12-227, 06-12-228, 06-12-247, 06-12-248, 06-12-249, 06-12-250, 06-12-251, 06-12-252, 06-12-253, 06-12-254, 06-12-255,   07-01-159, 0701-160, 07-01-161, 07-01-162, 07-01-163, 07-01-164, 07-01-165, 07-01-166, 07-01-167, 07-01-169, 07-01-170, 07-01-171, 07-01-187, 07-01-188, 07-01-189, 07-01-190, 07-01-191, 07-01-194, 07-01-195, 07-01-196, 07-01-197, 07-01-198, 07-01-199, 07-01-217, 07-01-218, 07-01-219, 07-01-220, 07-01-221, 07-01-222, 07-01-223, 07-01-224, 07-01-225, 07-01-226, 07-01-227, 07-01-228, 07-01-229, 07-01-230, 07-01-231, 07-01-232, 07-01-233, 07-01-234, 07-01-250, 07-01-251, 07-01-252, 07-01-253, 07-01-254, 07-01-255, 07-01-256, 07-01-257, 07-01-258, 07-01269, 07-01-207, 07-01-271, 07-01-272, 07-01-273, 07-01-274, 07-01-275, 07-01-276, 07-01-277, 07-01-421, 07-01-422, 07-01-423, 07-01-424, 07-01-428, 07-01-430, 07-01-431, 07-01-426, 07-01-427, 07-02-321, 07-02-324, 07-02-325, 07-02-326, 07-02-350, 07-02-351, 07-02-352, 07-02-358, 07-04-126,   07-01-200, 07-02-269,
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and inter- hospital transport.
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • Adresse du fabricant
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA