Events

Rappel de Drager V Series Ventilator with the Optional PS500 External Power Supply Unit installed

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Draeger Medical Australia Pty Ltd.

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
    RC-2017-RN-00176-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-02-06
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00176-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Dräger became aware that the battery capacity of the optional ps500 power supply unit was unexpectedly reduced. this resulted in batteries prematurely discharging, even though an adequate battery charge status was displayed. the "battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. when the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. the reported issue may cause unexpected loss of automatic ventilation functionality.Further to the recall for product correction in feb 2016 (tga ref.: rc-2016-rn-00154-1), dräger has now developed device modifications to rectify the issue.
  • Action
    The device modifications include the following:  - Installation of a new software 2.50 with improved battery charge management  - Improved charge management for external batteries  - Option of performing a battery check to determine the battery's current runtime  - Option of displaying the remaining battery capacity in minutes  - Installation of an additional internal backup battery  - Replacement of the power supply unit to support both the external battery and an additional internal battery  - Replacement of the existing external batteries. The installation of a backup battery will ensure that the internal battery will continue to supply power should the external battery fail. Users are advised to continue to observe the information in the Feb 2016 letter until the devices have been updated with the improved system.

Device

Drager V Series Ventilator with the Optional PS500 External Power Supply Unit installed
  • Modèle / numéro de série
    Drager V Series Ventilator with the Optional PS500 External Power Supply Unit installedAffected Models: Infinity V500; Evita V300; and Babylog VN500 All Serial Numbers affectedARTG Numbers: 158739, 170141 and 92177
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd