Events

Rappel de QUBE COMPACT MONITOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SPACELABS HEALTHCARE (CANADA) 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
    142161
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-02-04
  • 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
    Spacelabs has received multiple reports of xprezzon and qube monitors failing to boot up or returning to factory default configuration settings following power on or reset. reported issues include: -a failure to boot following power on or reset resulting in a failure in monitor operation. -loss of network connectivity which may result in i) an inability to display alarms and data from the affected monitor on central stations and other bedside monitors or ii) a failure to transmit parameter and alarms from the affected monitor to system printers and spacelabs' intesys clinical suite retrospective database (including the clinical events interface remote notification feature). -display of english language when previously configured for another language (the alarm messages displayed in the parameter waveform zone are not affected as these are stored on a command module and not on the monitor). -touchscreen failure where touching the screen does not produce the expected response. the parameter alarms and information are still present and correct once the monitor has completely started up. no one has been injured as a result of these issues. spacelabs believes this issue is caused by inadequate electrical contact on one of its printed circuit board assemblies.

Device

QUBE COMPACT MONITOR
  • Modèle / numéro de série
    Model Catalog: 91390 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 91393 (Lot serial: > 10 lot numbers contact mfg)
  • Description du dispositif
    QUBE COMPACT MONITOR
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

SPACELABS HEALTHCARE (CANADA) INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    HC