Events

Rappel de Device Recall Fabius GS Premium

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 Draeger Medical, 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
    79773
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1482-2018
  • Date de mise en oeuvre de l'événement
    2018-03-01
  • 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=163354
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Cause
    The automatic ventilation may fail if the position detection of the motor is disturbed. if the ventilator cover is damaged, manual ventilation may also fail.
  • Action
    On March 1, 2018, the recalling firm notified affected customers via an Urgent Medical Device Recall letter. The recalling firm stated that customers would receive replacement motors for potentially affected devices. Until the replacement occurred, customers were instructed to continue to operate their devices with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use. Customers were also supplied with a reply card to indicate that they had received the notification. Customers with questions about the letter were directed to call Michael Kelhart between 8AM-4:30PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). Questions regarding the operation and/or servicing of the Draeger Fabius anesthesia machine were directed to DraegerService Technical Support between the hours of 8:00 AM  8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).

Device

Device Recall Fabius GS Premium
  • Modèle / numéro de série
    Serial no: ASKF-0224 ASKF-0232 ASKH-0004 ASKH-0007 ASKH-0038 ASKH-0088 ASKH-0132 ASKH-0133 ASKJ-0007 ASKJ-0178 ASKJ-0179 ASKJ-0184 ASKJ-0205 ASKJ-0220 ASKJ-0224 ASKK-0002 ASKK-0006 ASKK-0010 ASKK-0011 ASKK-0014 ASKK-0019 ASKK-0022 ASKK-0023 ASKK-0032 ASKK-0036 ASKK-0038 ASKK-0044
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
  • Description du dispositif
    Fabius GS Premium, anesthesia machine, catalog no. 8607000 || Product Usage: || The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Adresse du fabricant
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Société-mère du fabricant (2017)
    Stefan Dräger GmbH
  • Source
    USFDA