Events

Rappel de Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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-2014-RN-01245-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-11-21
  • 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-2014-RN-01245-1
  • 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
    If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (pcba) and short to ground which may prevent the ventilator to switch to battery power if ac power is disrupted. a high urgency audible alarm will sound alerting medical personnel of the loss of power. in the absence of ac power, failure of battery power will cause loss of ventilator support which could result in hypercarbia or hypoxemia.
  • Action
    Philips is advising their customers to carry out a Power Fail Alarm Test as per the Operators Manual. If AC power is disrupted and the ventilator cannot switch to battery operation, a High Urgency alarm will sound and the patient must be supported with another means of life support ventilation. A new fan installation hardware kit will be installed on affected units. A Philips Field Service Engineer will be contacting customers to schedule the installation at no-cost. This action has been closed-out on 12/08/2016.

Device

Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics
  • Modèle / numéro de série
    Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics Part Numbers: 701-01000-00, C701-01000-00, DU701-01000-00, U701-01000-00Philips Part numbers : 989805611721, 989805643301, 989805612621, 989805613441ARTG Number: 134845
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA