Events

Rappel de Device Recall Perseus A500 Anesthesia Workstation

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
    72649
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0360-2016
  • Date de mise en oeuvre de l'événement
    2015-11-12
  • Date de publication de l'événement
    2015-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141791
  • 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
    There is a potential problem with the device main power switch of the perseus a500 anesthesia workstation. the device power switch may spontaneously fail during use, causing one of the following to occur: 1. the workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. the workstation shuts down completely with an audible alarm.
  • Action
    Draeger Medical, Inc. sent Urgent Medical Device Recall Letters, dated November 2015, to consignees on November 10, 2015. The letter identified the affected device and the reason for the recall. The device power switch of the affected workstations must be replace. Customers should refer to the list of affected serial numbers provided. A Drager Service Representative will contact customers to schedule the replacement free of charge, as soon as new switches are available. Until the replacement takes place, the workstation may only be operated under continuous supervision. Increased attention is necessary to notice the potential failure case early. All affected users should be informed. Customers can contact Michael Kelhart at 1-800-543-5047, (press 1 at the prompt, then 2, then 32349), with questions pertaining to the letter. Contact Drager Service Technical Support at 1-800-543-5047 for questions regarding the operation or servicing of the Drager Perseus A500.

Device

Device Recall Perseus A500 Anesthesia Workstation
  • Modèle / numéro de série
    ASHB-0140 ASHF-0039 ASHF-0055 ASHF-0056 ASHF-0057 ASHH-0008 ASHH-0009 ASHH-0010 ASHH-0011 ASHH-0012 ASHH-0013 ASHH-0014 ASHJ-0095 ASHJ-0096 ASHJ-0097 ASHJ-0098 ASHJ-0099 ASHK-0001 ASHK-0002 ASHK-0003 ASHK-0008 ASHK-0009 ASHK-0010 ASHK-0056 ASHK-0057 ASHK-0079 ASHK-0080 ASHK-0081 ASHK-0082 ASHK-oo83 ASHK-0084 ASHK-0085 ASHK-0086, and  ASHK-0087.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.
  • Description du dispositif
    Perseus A500 Anesthesia Workstation, MK06000. || Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
  • 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