Events

Alerte De Sécurité sur B20, B30 & B40 Patient Monitors

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-10-04
  • Date de publication de l'événement
    2013-10-04
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131004.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: ge healthcare b20, b30 & b40 patient monitors the therapeutic goods administration (tga), australia has issued a medical device safety alert concerning b20, b30 & b40 patient monitors, manufactured by ge healthcare. the serial numbers of the affected products are identified as follows:- b20 - sgf11030001wa to sgf13176741wa (software version 1) b30 - sf309380033wa to sf313177120wa (software version 2) b40 - sg211210001wa to sg213172146wa (software version 1) b40 - sjf13010005wa to sjf13180144wa (software version 2) the b20, b30 and b40 patient monitors set the ecg filter setting incorrectly if the monitor starts with impedance respiration set in the on position. instead of the user selected filter, an additional 0.5 hz high pass filter is used. the additional 0.5 hz high pass filter causes changes to the ecg waveform morphology and incorrect display of st values. the st-elevation measurement can be under-estimated in this situation and treatment of the patient can be delayed. the manufacturer is providing users with work around instructions to follow until a software correction is available. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01027-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 october 2013.

Device

B20, B30 & B40 Patient Monitors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare B20, B30 & B40 Patient Monitors”
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare