Events

Rappel de V60 VENTILATOR SYMBOLS ONLY WITH CFLEX AND AVAPS OPTIONS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHILIPS ELECTRONICS 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
    145464
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-04-26
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Over time low-frequency vibrations can cause the pins within the female connectors on the internal motor controller to data acquisition board ribbon cable to become partially displaced which causes momentary high resistance that interferes with data transfer. this may cause the ventilator to fail power on self testing (post) or cause continuous built in test (cbit) to detect a fault and lead to a ventilator shut down with alarm during use or during intra-hospital transport. if the v60 shuts down for any vent inop condition and is operating on battery power an audible high-priority alarm will sound continuously for at least 2 minutes. if the v60 is connected to ac power (mains supply) the alarm will continue to sound until an operator intervenes. if the v60 is connected to a remote alarm system the alarm system will be activated until action is taken by the operator. the device may display an error code 100a 1006 1007 or 1008 on the screen. displaying one of these error codes indicates that the ventilator has had a communication failure that may be caused by the cable.

Device

V60 VENTILATOR SYMBOLS ONLY WITH CFLEX AND AVAPS OPTIONS
  • Modèle / numéro de série
    Model Catalog: 1053614 (Lot serial: ALL)
  • Description du dispositif
    V60 VENTILATOR SYMBOLS ONLY WITH CFLEX AND AVAPS OPTIONS
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC